Trial Outcomes & Findings for Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (NCT NCT05523297)

NCT ID: NCT05523297

Last Updated: 2025-08-15

Results Overview

Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII \[rFVIIa\], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 420 participants
• Primary outcome timeframe: 60 minutes to 24 hours after first dose of IMP
• Results posted on: 2025-08-15

Participant Flow

Participants were recruited based on physician referral at 10 Canadian sites and 2 US sites. The first participant was enrolled in November 2022 and the last patient completed the study in June 2024.

Of 538 enrolled participants, 420 met the inclusion criteria and were randomized to treatment.

Participant milestones

Measure	Octaplex Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Overall Study STARTED	213	207
Overall Study Per-protocol Population (PP)	209	200
Overall Study COMPLETED	204	198
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Measure	Octaplex Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Overall Study Death	7	8
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

Baseline characteristics by cohort

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human	Total n=420 Participants Total of all reporting groups
Age, Continuous	63.97 years STANDARD_DEVIATION 13.596 • n=5 Participants	61.68 years STANDARD_DEVIATION 14.002 • n=7 Participants	62.84 years STANDARD_DEVIATION 13.829 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants	152 Participants n=7 Participants	309 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	132 Participants n=7 Participants	264 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	79 Participants n=5 Participants	73 Participants n=7 Participants	152 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	138 Participants n=5 Participants	137 Participants n=7 Participants	275 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	49 Participants n=5 Participants	45 Participants n=7 Participants	94 Participants n=5 Participants
Body Height	171.03 centimeter (cm) STANDARD_DEVIATION 10.082 • n=5 Participants	171.83 centimeter (cm) STANDARD_DEVIATION 10.565 • n=7 Participants	171.42 centimeter (cm) STANDARD_DEVIATION 10.318 • n=5 Participants
Body Weight	84.63 kilogram (kg) STANDARD_DEVIATION 19.344 • n=5 Participants	83.62 kilogram (kg) STANDARD_DEVIATION 19.520 • n=7 Participants	84.13 kilogram (kg) STANDARD_DEVIATION 19.414 • n=5 Participants
Body Mass Index (BMI)	28.88 kilogram per square meter (kg/m²) STANDARD_DEVIATION 5.986 • n=5 Participants	28.20 kilogram per square meter (kg/m²) STANDARD_DEVIATION 5.403 • n=7 Participants	28.55 kilogram per square meter (kg/m²) STANDARD_DEVIATION 5.710 • n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes to 24 hours after first dose of IMP

Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII [rFVIIa], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Number of Patients Requiring Additional Hemostatic Intervention Effective	166 Participants	125 Participants
Number of Patients Requiring Additional Hemostatic Intervention Ineffective	47 Participants	82 Participants

SECONDARY outcome

Timeframe: 60 minutes to 24 hours after first dose of IMP

Population: Data were not available for 2 patients in the FP group due to missing hemoglobin values.

Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by <30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP.

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=205 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels Negative	56 Participants	83 Participants
Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels Positive	157 Participants	122 Participants

SECONDARY outcome

Timeframe: 12 and 24 hours after chest closure

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. 12 hours after chest closure	471.20 Milliliters (mL) Standard Deviation 358.32	641.90 Milliliters (mL) Standard Deviation 465.17
Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. 24 hours after chest closure	690.90 Milliliters (mL) Standard Deviation 465.62	922.90 Milliliters (mL) Standard Deviation 631.90

SECONDARY outcome

Timeframe: 24 hours after surgery start, after the end of CPB and after IMP initiation

Yes or no refers to whether severe to massive bleeding was present.

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after IMP start · No	183 Participants	136 Participants
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after IMP start · Yes	30 Participants	71 Participants
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after surgery start · No	176 Participants	129 Participants
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after surgery start · Yes	37 Participants	78 Participants
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after CBP end · No	183 Participants	136 Participants
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). Within 24 hours after CBP end · Yes	30 Participants	71 Participants

SECONDARY outcome

Timeframe: First 24 hours after the end of CPB

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups.	6.61 total ABPs Standard Deviation 6.95	13.79 total ABPs Standard Deviation 11.42

SECONDARY outcome

Timeframe: First 24 hours after the end of CPB

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups.	6.61 total non-IMP ABPs Standard Deviation 6.95	9.33 total non-IMP ABPs Standard Deviation 10.64

SECONDARY outcome

Timeframe: First 24 hours and 7 days after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. During the first 24 hours after IMP start	4.14 Total non-IMP ABPs Standard Deviation 6.25	6.73 Total non-IMP ABPs Standard Deviation 10.14
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. During the first 7 days after IMP start	5.20 Total non-IMP ABPs Standard Deviation 8.43	8.87 Total non-IMP ABPs Standard Deviation 16.04

SECONDARY outcome

Timeframe: 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP including IMP (During the first 24 hours after IMP start)	0.19 ABPs Standard Deviation 1.12	4.70 ABPs Standard Deviation 2.47
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (During the first 24 hours after IMP start)	0.19 ABPs Standard Deviation 1.12	0.23 ABPs Standard Deviation 1.63
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. RBCs (During the first 24 hours after IMP start)	1.05 ABPs Standard Deviation 1.72	2.02 ABPs Standard Deviation 2.58
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (During the first 24 hours after IMP start)	2.89 ABPs Standard Deviation 4.50	4.48 ABPs Standard Deviation 6.80
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (During the first 24 hours after IMP start)	0.08 ABPs Standard Deviation 0.42	0.14 ABPs Standard Deviation 0.61
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP including IMP (During the first 7 days after IMP start)	0.23 ABPs Standard Deviation 1.273	7.25 ABPs Standard Deviation 34.818
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (During the first 7 days after IMP start)	0.23 ABPs Standard Deviation 1.273	2.78 ABPs Standard Deviation 34.792
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Red blood cells (During the first 7 days after IMP start)	1.7 ABPs Standard Deviation 2.378	2.9 ABPs Standard Deviation 3.466
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (During the first 7 days after IMP start)	3.27 ABPs Standard Deviation 5.827	5.6 ABPs Standard Deviation 11.530
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (During the first 7 days after IMP start)	0.08 ABPs Standard Deviation 0.421	0.16 ABPs Standard Deviation 0.765

SECONDARY outcome

Timeframe: 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (Within 24 hours after IMP start) · No	205 Participants	200 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (Within 24 hours after IMP start) · Yes	8 Participants	7 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. RBCs (Within 24 hours after IMP start) · No	116 Participants	75 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. RBCs (Within 24 hours after IMP start) · Yes	97 Participants	132 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (Within 24 hours after IMP start) · No	116 Participants	99 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (Within 24 hours after IMP start) · Yes	97 Participants	108 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (Within 24 hours after IMP start) · No	204 Participants	195 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (Within 24 hours after IMP start) · Yes	9 Participants	12 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Any individual ABP (Within 24 hours after IMP start) · No	82 Participants	56 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Any individual ABP (Within 24 hours after IMP start) · Yes	131 Participants	151 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (Within 7 days after IMP start) · No	205 Participants	195 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. FP excluding IMP (Within 7 days after IMP start) · Yes	8 Participants	12 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. RBCs (Within 7 days after IMP start) · No	82 Participants	53 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. RBCs (Within 7 days after IMP start) · Yes	131 Participants	154 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (Within 7 days after IMP start) · No	112 Participants	97 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Platelets (Within 7 days after IMP start) · Yes	101 Participants	110 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (Within 7 days after IMP start) · No	204 Participants	195 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Cryoprecipitate (Within 7 days after IMP start) · Yes	9 Participants	12 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Any individual ABP (Within 7 days after IMP start) · No	58 Participants	40 Participants
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. Any individual ABP (Within 7 days after IMP start) · Yes	155 Participants	167 Participants

SECONDARY outcome

Timeframe: 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Fibrinogen concentrate (Within 24 hours after IMP start) · No	167 Participants	159 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Fibrinogen concentrate (Within 24 hours after IMP start) · Yes	46 Participants	48 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups rFVIIa (Within 24 hours after IMP start) · No	211 Participants	197 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups rFVIIa (Within 24 hours after IMP start) · Yes	2 Participants	10 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups PCC excluding IMP (Within 24 hours after IMP start) · No	212 Participants	190 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups PCC excluding IMP (Within 24 hours after IMP start) · Yes	1 Participants	17 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Any coagulation factor product (Within 24 hours after IMP start) · No	164 Participants	148 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Any coagulation factor product (Within 24 hours after IMP start) · Yes	49 Participants	59 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Fibrinogen concentrate (Within 7 days after IMP start) · No	167 Participants	156 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Fibrinogen concentrate (Within 7 days after IMP start) · Yes	46 Participants	51 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups rFVIIa (Within 7 days after IMP start) · No	211 Participants	197 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups rFVIIa (Within 7 days after IMP start) · Yes	2 Participants	10 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups PCC excluding IMP (Within 7 days after IMP start) · No	212 Participants	190 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups PCC excluding IMP (Within 7 days after IMP start) · Yes	1 Participants	17 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Any coagulation factor product (Within 7 days after IMP start) · No	164 Participants	145 Participants
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups Any coagulation factor product (Within 7 days after IMP start) · Yes	49 Participants	62 Participants

SECONDARY outcome

Timeframe: 24 hours after start of surgery, after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups 24 hours after start of surgery	0 participants	0 participants
Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups After the end of CPB	0 participants	0 participants
Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups After IMP initiation	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 hours after start of surgery, after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups 24 hours after start of surgery	0 participants	0 participants
Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups After the end of CPB	0 participants	0 participants
Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups After IMP initiation	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 hours after start of surgery, after the end of CPB and after IMP initiation

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after surgery start · No	200 Participants	189 Participants
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after surgery start · Yes	13 Participants	18 Participants
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after CPB end · No	199 Participants	187 Participants
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after CPB end · Yes	14 Participants	20 Participants
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after IMP start · No	199 Participants	187 Participants
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups Within 24 hours after IMP start · Yes	14 Participants	20 Participants

SECONDARY outcome

Timeframe: Within 30 minutes before to 60 minutes after the initiation of IMP administration.

Population: The analysis of absolute change included all patients who had INR data available at both pre- and post-IMP time points.

The international normalized ratio (INR) is a standardized measure of prothrombin time (PT), ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the INR.

INR reduction was considered successful if the magnitude of the reduction was >1.0 or the post-treatment level dropped below 1.5 (INR >1.5 indicates that one or more coagulation factor levels are below the 30% critical threshold)

Outcome measures

Measure	Octaplex n=200 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=193 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration.	-0.9 international normalised ratio (INR) Standard Deviation 0.76	-0.7 international normalised ratio (INR) Standard Deviation 0.91

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

The prothrombin time (PT) measures the time it takes for clotting to occur, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factors V, VII, and X and prothrombin, and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the PT.

Outcome measures

Measure	Octaplex n=9 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=1 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT)	-10.3 seconds Standard Deviation 20.90	-0.7 seconds Standard Deviation NA SD not available (n=1).

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Activated partial thromboplastin time (aPTT) is a standard laboratory test that measures how long it takes (in seconds) for clotting to occur (in the presence of an activator). It evaluates the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Prolonged aPTT may signify deficiencies in these clotting factors and is associated with bleeding. Effective procoagulant therapy can shorten/normalize the aPTT.

Outcome measures

Measure	Octaplex n=4 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=1 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT)	-63.5 seconds Standard Deviation 121.47	-45.6 seconds Standard Deviation NA SD not available (n=1).

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Outcome measures

Measure	Octaplex n=4 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=2 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity	0.1 grams per liter (g/L) Standard Deviation 0.07	0.5 grams per liter (g/L) Standard Deviation 0.57

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Population: Few data were available as ROTEM measurements were not mandated by the study protocol.

A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with clotting time (CT) providing a measure (in seconds) of how quickly a clot starts forming. Prolonged EXTEM CT is associated with bleeding. Effective procoagulant therapy can reduce/normalize the EXTEM CT.

Outcome measures

Measure	Octaplex n=11 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=15 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT	-21.5 seconds Standard Deviation 18.00	-21.7 seconds Standard Deviation 18.65

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Population: Few data were available as ROTEM measurements were not mandated by the study protocol.

A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with maximum clot firmness (MCF) providing a measure (in mm) of the strength of the clot. Reduced EXTEM MCF is associated with bleeding. Effective procoagulant therapy can increase/normalize the EXTEM MCF.

Outcome measures

Measure	Octaplex n=11 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=15 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF	3.6 Millimeters (mm) Standard Deviation 4.95	6.7 Millimeters (mm) Standard Deviation 9.54

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Population: Few data were available as ROTEM measurements were not mandated by the study protocol.

A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the FIBTEM test evaluates fibrin-based clotting - it is extrinsically activated with tissue factor and additionally incorporates an inhibitor to eliminate the contribution of platelets to clotting. Maximum clot firmness (MCF) in the FIBTEM test provides a measure (in mm) of the strength of the fibrin-based clot. Reduced FIBTEM MCF is associated with bleeding. Effective procoagulant therapy to restore fibrinogen can increase/normalize the FIBTEM MCF.

Outcome measures

Measure	Octaplex n=11 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=15 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF	3.8 Millimeters (mm) Standard Deviation 2.75	1.4 Millimeters (mm) Standard Deviation 13.78

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Population: The analysis of absolute change included all patients who had coagulation parameter data available at both pre- and post-IMP time points.

Outcome measures

Measure	Octaplex n=15 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=14 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks	-2.3 10^9 platelets/L Standard Deviation 22.97	10.9 10^9 platelets/L Standard Deviation 38.29

SECONDARY outcome

Timeframe: Within 75 minutes before to within 75 minutes after the initiation of IMP administration

Population: The analysis of absolute change included all patients who had coagulation parameter data available at both pre- and post-IMP time points.

The Plateletworks device (Helena Laboratories) enables rapid bedside screening of platelet function. The system uses an impedance cell counter and Plateletworks reagent tubes to evaluate platelet function and monitor treatment effects. By comparing a baseline total platelet count against the platelet count measured in the presence of an agonist used to stimulate platelet aggregation (ADP, collagen, or arachidonic acid), the tests determine the percent aggregation or inhibition of functional platelets. Manufacturer reference ranges, determined by testing blood samples from healthy volunteers, are 86-100% for ADP, 70-100% for collagen, and 60-100% for arachidonic acid. Values within these ranges indicate 'normal (positive)' platelet aggregation, which is important for clotting; lower values may be considered 'abnormal (negative)' and reflective of platelet inhibition. The manufacturer advises each laboratory to establish their own reference ranges for their patient population.

Outcome measures

Measure	Octaplex n=10 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=13 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks	-5.9 percentage Standard Deviation 10.34	-18.2 percentage Standard Deviation 17.72

SECONDARY outcome

Timeframe: From initiation of IMP to arrival at ICU room (within 24 hours)

Population: 37 patients were excluded from the analysis population. 27 (12 in the Octaplex group, 25 in the FP group) who were already in the ICU when the first dose of IMP was initiated, 5 patients (2 in the Octaplex group, 3 in the FP group) for whom the time intervals could not be calculated due to incomplete date/time of arrival at ICU, and 1 patient (FP group) who was not in the ICU, therefore the time interval could not be calculated.

Outcome measures

Measure	Octaplex n=199 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=178 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups.	1.0 hours Interval 0.6 to 1.7	1.2 hours Interval 0.7 to 2.0

SECONDARY outcome

Timeframe: From the beginning of surgery up to postoperative day 30

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups	77 Participants	98 Participants

SECONDARY outcome

Timeframe: From the beginning of surgery up to postoperative day 30

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups	1.0 days Interval 1.0 to 2.0	1.0 days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From the beginning of surgery up to postoperative day 30

Population: Three patients in the FP group were excluded from this analysis due to missing dates of ICU stays

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=204 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Duration of ICU Stay Between Octaplex and FP Groups	4 days Interval 2.0 to 6.0	4 days Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: From the beginning of surgery up to postoperative day 30

Population: One patient in the FP group was excluded from analysis due to missing data

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=206 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Duration of Hospitalization Between Octaplex and FP Groups	8 days Interval 7.0 to 12.0	9 days Interval 7.0 to 13.0

SECONDARY outcome

Timeframe: Up to 30 days after the end of CPB

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Incidence of Death Between Octaplex and FP Groups	7 Participants	8 Participants

SECONDARY outcome

Timeframe: From the beginning of surgery up to postoperative day 30

Population: One participant is excluded from analysis due to missing start/end date of hospitalization.

Outcome measures

Measure	Octaplex n=213 Participants Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=206 Participants Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups	21.0 days Interval 17.0 to 23.0	21.0 days Interval 16.0 to 23.0

Adverse Events

Octaplex

Serious events: 77 serious events

Other events: 206 other events

Deaths: 7 deaths

Frozen Plasma

Serious events: 98 serious events

Other events: 201 other events

Deaths: 8 deaths

Serious adverse events

Measure	Octaplex n=213 participants at risk Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 participants at risk Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Infections and infestations Anal abscess	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Endocarditis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Gall bladder abscess	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Gangrene	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Graft infection	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Klebsiella bacteremia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Mediastinitis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia aspiration	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia bacterial	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia escherichia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia klebsiella	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia pseudomonal	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Post procedural pneumonia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Post procedural sepsis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Prosthetic valve endocarditis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Sepsis	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Infections and infestations Septic shock	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Infections and infestations Staphylococcal bacteremia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Stenotrophomonas bacteremia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Stenotrophomonas maltophilia pneumonia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Urinary tract infection pseudomonal	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Infections and infestations Wound infection	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Splenic infarction	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Thrombocytopenia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Immune system disorders Anaphylactic shock	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Endocrine disorders Adrenal insufficiency	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hyperkalemia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypervolemia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypokalemia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hyponatremia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Delirium	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Altered state of consciousness	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Cerebrovascular accident	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Embolic stroke	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Encephalopathy	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Ischemic stroke	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Metabolic encephalopathy	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Seizure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Acute right ventricular failure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Arrhythmia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrial fibrillation	3.3% 7/213 • Number of events 7 • From beginning of surgery to 30 days after surgery start	3.9% 8/207 • Number of events 10 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrial flutter	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block complete	4.2% 9/213 • Number of events 9 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block second degree	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac arrest	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac failure congestive	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac tamponade	3.8% 8/213 • Number of events 8 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardio-respiratory arrest	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiogenic shock	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	3.9% 8/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Carditis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Coronary artery occlusion	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Dressler's syndrome	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Intrapericardial thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Low cardiac output syndrome	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Myocardial infarction	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Nodal arrhythmia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Nodal rhythm	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pericardial effusion	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pericarditis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pulseless electrical activity	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Right ventricular dysfunction	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Right ventricular failure	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Sinus node dysfunction	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Supraventricular tachycardia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Ventricular tachycardia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Vascular disorders Aortic thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Arterial hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Deep vein thrombosis	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Vascular disorders Distributive shock	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Extremity necrosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hypertension	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hypotension	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Jugular vein thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Obstructive shock	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Peripheral artery thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Peripheral ischemia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Vascular disorders Shock	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Vascular disorders Shock hemorrhagic	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Subclavian vein thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Superficial vein thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Vascular disorders Thrombosis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Venous hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Hemothorax	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Hypoxia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Mediastinal hematoma	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Mediastinal hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pulmonary necrosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	5.3% 11/207 • Number of events 11 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Thoracic hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Gastrointestinal hemorrhage	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Intestinal ischemia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Hepatic failure	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Ischemic hepatitis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Liver injury	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Skin and subcutaneous tissue disorders Skin discoloration	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Acute kidney injury	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	4.8% 10/207 • Number of events 10 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Renal failure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Renal tubular necrosis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Reproductive system and breast disorders Scrotum erosion	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
General disorders Catheter site thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
General disorders Death	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
General disorders Generalised edema	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
General disorders Multiple organ dysfunction syndrome	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
General disorders Edema peripheral	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
General disorders Prosthetic cardiac valve thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
General disorders Vessel puncture site thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Investigations Anticoagulation drug level above therapeutic	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Investigations Hepatic enzyme increased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Complications of transplanted kidney	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Dilutional coagulopathy	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Graft hemorrhage	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Head injury	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Post procedural hemorrhage	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Procedural hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Procedural shock	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Transfusion-related circulatory overload	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Traumatic hemothorax	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Vasoplegia syndrome	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Venous injury	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Product Issues Device pacing issue	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start

Other adverse events

Measure	Octaplex n=213 participants at risk Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate	Frozen Plasma n=207 participants at risk Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	1.4% 3/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Leukocytosis	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Splenic infarction	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Thrombocytopenia	4.7% 10/213 • Number of events 10 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Immune system disorders Hypersensitivity	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Acidosis	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Alkalosis hypochloremic	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Decreased appetite	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hyperglycemia	6.6% 14/213 • Number of events 14 • From beginning of surgery to 30 days after surgery start	5.8% 12/207 • Number of events 12 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hyperkalemia	4.2% 9/213 • Number of events 9 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypervolemia	18.3% 39/213 • Number of events 39 • From beginning of surgery to 30 days after surgery start	20.3% 42/207 • Number of events 42 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypoalbuminemia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypocalcemia	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypoglycemia	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypokalemia	4.2% 9/213 • Number of events 11 • From beginning of surgery to 30 days after surgery start	7.2% 15/207 • Number of events 15 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hyponatremia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypophosphatemia	4.2% 9/213 • Number of events 9 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Hypovolemia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Lactic acidosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Metabolism and nutrition disorders Metabolic acidosis	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Agitation	0.47% 1/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Anxiety	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Confusional state	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Delirium	7.5% 16/213 • Number of events 16 • From beginning of surgery to 30 days after surgery start	6.8% 14/207 • Number of events 14 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Hallucination, visual	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Psychiatric disorders Insomnia	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Altered state of consciousness	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Cerebrovascular accident	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Infections and infestations Bronchitis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Infections and infestations Cellulitis	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Clostridium difficile infection	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations COVID-19	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Infections and infestations Localised infection	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Oral candidiasis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Infections and infestations Pneumonia klebsiella	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Postoperative wound infection	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Infections and infestations Sepsis	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Infections and infestations Septic shock	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Infections and infestations Urinary tract infection	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Infections and infestations Urinary tract infection bacterial	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Infections and infestations Wound infection	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Blood and lymphatic system disorders Anemia	30.5% 65/213 • Number of events 65 • From beginning of surgery to 30 days after surgery start	31.9% 66/207 • Number of events 66 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Cognitive disorder	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Nervous system disorders ICU acquired weakness	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Migraine	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Nystagmus	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Paresthesia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Seizure	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Nervous system disorders Syncope	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Accelerated idioventricular rhythm	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Arrhythmia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrial fibrillation	40.8% 87/213 • Number of events 93 • From beginning of surgery to 30 days after surgery start	30.9% 64/207 • Number of events 68 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrial flutter	5.2% 11/213 • Number of events 11 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrial tachycardia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block complete	4.2% 9/213 • Number of events 9 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block first degree	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Atrioventricular block second degree	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Bradycardia	2.8% 6/213 • Number of events 6 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Bundle branch block left	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Bundle branch block right	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac arrest	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac failure congestive	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiac tamponade	3.8% 8/213 • Number of events 8 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Cardiogenic shock	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	3.9% 8/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Dressler's syndrome	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Nodal arrhythmia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Nodal rhythm	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pericardial effusion	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	3.9% 8/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pericarditis	5.2% 11/213 • Number of events 11 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Pulseless electrical activity	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Right ventricular dysfunction	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Right ventricular failure	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Sinus bradycardia	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Sinus node dysfunction	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Sinus tachycardia	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Supraventricular extrasystoles	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Supraventricular tachycardia	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Tachycardia	3.3% 7/213 • Number of events 7 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Ventricular extrasystoles	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Cardiac disorders Ventricular tachycardia	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Vascular disorders Deep vein thrombosis	1.9% 4/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Vascular disorders Distributive shock	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Extremity necrosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hematoma	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hemorrhage	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hypertension	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Vascular disorders Hypotension	8.0% 17/213 • Number of events 18 • From beginning of surgery to 30 days after surgery start	12.6% 26/207 • Number of events 27 • From beginning of surgery to 30 days after surgery start
Vascular disorders Peripheral ischemia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Vascular disorders Phlebitis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Vascular disorders Shock	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Atelectasis	3.8% 8/213 • Number of events 8 • From beginning of surgery to 30 days after surgery start	5.3% 11/207 • Number of events 12 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Cough	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Epistaxis	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Hemothorax	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 7/213 • Number of events 7 • From beginning of surgery to 30 days after surgery start	4.3% 9/207 • Number of events 9 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.1% 28/213 • Number of events 29 • From beginning of surgery to 30 days after surgery start	20.3% 42/207 • Number of events 44 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pneumothorax	13.1% 28/213 • Number of events 30 • From beginning of surgery to 30 days after surgery start	3.9% 8/207 • Number of events 8 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Rales	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	7.2% 15/207 • Number of events 15 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Rhonchi	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Tachypnea	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Thoracic hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Respiratory, thoracic and mediastinal disorders Wheezing	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Abdominal distension	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Abdominal pain	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Constipation	2.8% 6/213 • Number of events 6 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Diarrhea	2.8% 6/213 • Number of events 6 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Dysphagia	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Gastrointestinal hemorrhage	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Intestinal ischemia	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Nausea	10.8% 23/213 • Number of events 23 • From beginning of surgery to 30 days after surgery start	7.2% 15/207 • Number of events 15 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Gastrointestinal disorders Vomiting	2.8% 6/213 • Number of events 6 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Hepatic failure	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Hypertransaminasemia	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Hepatobiliary disorders Ischemic hepatitis	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Skin and subcutaneous tissue disorders Decubitus ulcer	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Skin and subcutaneous tissue disorders Erythema	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Skin and subcutaneous tissue disorders Rash	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Musculoskeletal and connective tissue disorders Back pain	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Musculoskeletal and connective tissue disorders Muscle spasms	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Acute kidney injury	9.9% 21/213 • Number of events 21 • From beginning of surgery to 30 days after surgery start	17.4% 36/207 • Number of events 36 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Hematuria	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Oliguria	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Renal failure	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Renal and urinary disorders Urinary retention	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
General disorders Chest pain	2.3% 5/213 • Number of events 5 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
General disorders Chills	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
General disorders Generalised edema	0.47% 1/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
General disorders Multiple organ dysfunction syndrome	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
General disorders Edema	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
General disorders Edema peripheral	15.5% 33/213 • Number of events 33 • From beginning of surgery to 30 days after surgery start	13.5% 28/207 • Number of events 28 • From beginning of surgery to 30 days after surgery start
General disorders Prosthetic cardiac valve thrombosis	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
General disorders Pyrexia	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Investigations Activated partial thromboplastin time prolonged	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Investigations Alanine aminotransferase increased	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Blood bilirubin increased	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Investigations Blood creatinine increased	4.2% 9/213 • Number of events 9 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Investigations Blood lactic acid increased	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Investigations Blood potassium decreased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Breath sounds abnormal	3.3% 7/213 • Number of events 7 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Investigations Chest X-ray abnormal	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Investigations Coagulation factor increased	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Investigations Ejection fraction decreased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Hemoglobin decreased	7.5% 16/213 • Number of events 17 • From beginning of surgery to 30 days after surgery start	7.7% 16/207 • Number of events 16 • From beginning of surgery to 30 days after surgery start
Investigations Heart rate increased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Hepatic enzyme increased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Investigations INR increased	1.4% 3/213 • Number of events 3 • From beginning of surgery to 30 days after surgery start	0.00% 0/207 • From beginning of surgery to 30 days after surgery start
Investigations Liver function test increased	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Investigations Oxygen saturation decreased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Platelet count decreased	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Investigations Troponin increased	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.9% 4/207 • Number of events 4 • From beginning of surgery to 30 days after surgery start
Investigations Urine output decreased	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations Venous oxygen saturation decreased	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Investigations White blood cell count increased	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Anemia postoperative	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	2.9% 6/207 • Number of events 6 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Head injury	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Incision site pain	0.94% 2/213 • Number of events 2 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Post procedural hemorrhage	1.9% 4/213 • Number of events 4 • From beginning of surgery to 30 days after surgery start	4.8% 10/207 • Number of events 10 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Postoperative delirium	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	3.4% 7/207 • Number of events 7 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	1.4% 3/207 • Number of events 3 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.48% 1/207 • Number of events 1 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Procedural hemorrhage	0.00% 0/213 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Procedural pain	5.6% 12/213 • Number of events 12 • From beginning of surgery to 30 days after surgery start	5.3% 11/207 • Number of events 11 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Vasoplegia syndrome	2.8% 6/213 • Number of events 6 • From beginning of surgery to 30 days after surgery start	2.4% 5/207 • Number of events 5 • From beginning of surgery to 30 days after surgery start
Injury, poisoning and procedural complications Wound complication	0.47% 1/213 • Number of events 1 • From beginning of surgery to 30 days after surgery start	0.97% 2/207 • Number of events 2 • From beginning of surgery to 30 days after surgery start

Additional Information

Dr Keyvan Karkouti

Toronto General Hospital

Phone: (416) 340-8597

Email: keyvan.karkouti@uhn.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place