Trial Outcomes & Findings for Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery (NCT NCT01623531)

NCT ID: NCT01623531

Last Updated: 2020-05-22

Results Overview

Including packed red cells, frozen plasma, platelets, cryoprecipitates

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: 24 hours after administration of study drug
• Results posted on: 2020-05-22

Participant Flow

The investigation included 62 patients (>18 years old) for elective, high-risk cardiac surgery (double procedures (aortic valve replacement (AVR)+coronary artery bypass grafting (CABG), mitral valve repair/replacement (MVR)+CABG, AVR+MVR), redo-sternotomies, and aortic root repair±AVR) with a pre-operative fibrinogen level of ≤3.8 g/L.

Participant milestones

Measure	RiaSTAP Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous saline will be administered with the same volume as study drug
Overall Study STARTED	31	31
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	RiaSTAP Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous saline will be administered with the same volume as study drug
Overall Study Death	1	0
Overall Study Protocol Violation	2	1
Overall Study Missing data at primary outcome time poi	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	RiaSTAP n=28 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=30 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous saline will be infused with the same volume of the study drug.	Total n=58 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 18 • n=28 Participants	65 years STANDARD_DEVIATION 11 • n=30 Participants	62 years STANDARD_DEVIATION 14 • n=58 Participants
Sex: Female, Male Female	5 Participants n=28 Participants	3 Participants n=30 Participants	8 Participants n=58 Participants
Sex: Female, Male Male	23 Participants n=28 Participants	27 Participants n=30 Participants	50 Participants n=58 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	28 participants n=28 Participants	30 participants n=30 Participants	58 participants n=58 Participants
Body Mass Index	28.8 kg/m^2 STANDARD_DEVIATION 4.14 • n=28 Participants	29 kg/m^2 STANDARD_DEVIATION 4.03 • n=30 Participants	28.9 kg/m^2 STANDARD_DEVIATION 4 • n=58 Participants

PRIMARY outcome

Timeframe: 24 hours after administration of study drug

Including packed red cells, frozen plasma, platelets, cryoprecipitates

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Cumulative Transfusion Units	0 Transfusion Units Interval 0.0 to 1.0	0 Transfusion Units Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Six patients had missing data in the fibrinogen group (RiaStap) at 24h after infusion of study drug. Six patients had missing data in the placebo group at 24h after infusion of study drug.

Outcome measures

Measure	RiaSTAP n=22 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=24 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Fibrinogen Plasma Concentration (g/L)	4.65 g/L Standard Deviation 0.94	4.15 g/L Standard Deviation 0.68

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Two patients in the placebo group had missing data at 24h after infusion of study drug.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=28 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Hematocrit (%)	0.29 Hematocrit percent Standard Deviation 0.04	0.28 Hematocrit percent Standard Deviation 0.05

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Two patients in the placebo group had missing data at 24h after infusion of study drug.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=28 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Hemoglobin Concentration (g/L)	95 g/L Standard Deviation 11.9	95 g/L Standard Deviation 14.8

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Two patients in the placebo group had missing data at 24h after infusion of study drug.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=28 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Platelet Count (10^3/μL)	129 cells*10^3/μL Standard Deviation 31.4	117 cells*10^3/μL Standard Deviation 29.3

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Two patients in the placebo group had missing data at 24h after infusion of study drug.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=28 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Partial Thromboplastin Time (s)	31 seconds Interval 27.0 to 33.0	28.5 seconds Interval 27.0 to 30.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Three patients in the placebo group had missing data at 24h after infusion of study drug.

International normalized ratio (INR) is calculated based on the prothrombin time (PT) test results.The PT is usually measured in seconds and is compared to a normal range that reflects PT values in healthy individuals. Because the reagents used to perform the PT test vary from one laboratory to another and even within the same laboratory over time, the normal ranges also will fluctuate. To standardize results across different laboratories in the world, a World Health Organization (WHO) committee developed and recommended the use of the Internationalized Normalized Ratio (INR). The INR is calculated with the ratio of the patient's prothrombin time (PT test) to a normal prothrombin time (control) sample (PT normal): INR=PT test:PT normal. The normal range is from 0.9 to 1.2. The higher the value the more is the patient anticoagulated. This means the patient's blood is thinner with a lower concentration of coagulation factors.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=27 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
International Normalized Ratio	1.2 Ratio Interval 1.0 to 1.9	1.2 Ratio Interval 1.0 to 1.5

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: Four patients in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. Three patients in the placebo group had missing data at 24h after infusion of study drug.

The prothrombin time (PT) test evaluates how well all of the coagulation factors in the extrinsic and common pathways of the coagulation cascade work together. Included are: factors I (Fibrinogen), II (Prothrombin), V, VII and X.

Outcome measures

Measure	RiaSTAP n=24 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=27 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Prothrombin Time (s)	13.9 seconds Interval 13.0 to 15.0	13.8 seconds Interval 13.0 to 15.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
EXTEM Clotting Time (s)	68 seconds Interval 63.0 to 74.0	68 seconds Interval 62.0 to 75.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

EXTEM = rotational thrombelastometry (measurement of extrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
EXTEM Maximum Clot Firmness (mm)	66 mm Interval 63.0 to 70.0	64 mm Interval 61.0 to 67.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
INTEM Clotting Time (s)	161 seconds Interval 146.0 to 175.0	164 seconds Interval 148.0 to 167.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

INTEM = rotational thrombelastometry (measurement of intrinsic coagulation pathway); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
INTEM Maximum Clot Firmness (mm)	64 mm Interval 63.0 to 68.0	63 mm Interval 50.0 to 66.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

FIBTEM = rotational thrombelastometry (measurement of functional fibrinogen); clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
FIBTEM Clotting Time (s)	64 seconds Interval 56.0 to 67.0	59 seconds Interval 54.0 to 67.0

SECONDARY outcome

Timeframe: 24 hours after study drug administration

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

Rotational thrombelastometry (measurement of functional fibrinogen). Rotational thrombelastometry (ROTEM) is a point-of-care viscoelastic coagulation test. The device provides four channels for simultaneous assays. With the so called "FIBTEM" assay coagulation is activated by a small amount of tissue thromboplastin (tissue factor) and platelets are blocked with cytochalasin D. The resulting clot is therefore only depending on fibrin formation and fibrin polymerisation. The maximum clot firmness (MCF) is the amplitude in mm on the result graph representing the increasing stabilisation of the clot.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
FIBTEM MCF (Maximum Clot Firmness)	27 mm Interval 24.0 to 30.0	23 mm Interval 22.0 to 27.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase);clotting time: time from start of the measurement until initiation of clotting (thrombin formation, start of clot polymerisation).

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
HEPTEM Clotting Time (s)	162 seconds Interval 152.0 to 184.0	162 seconds Interval 149.0 to 172.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

HEPTEM = rotational thrombelastometry (measurement of INTEM with heparinase); maximum clot firmness: increasing stabilisation of the clot by the polymerised fibrin, platelets as well as factor XIII.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
HEPTEM Maximum Clot Firmness (mm)	62 mm Interval 58.0 to 67.0	61 mm Interval 58.0 to 63.0

SECONDARY outcome

Timeframe: 24h after infusion of study drug

Population: One patient in the fibrinogen group (RiaStap) had missing data at 24h after infusion of study drug. One patient in the placebo group had missing data at 24h after infusion of study drug.

Total avoidance of any transfusion after cardiopulmonary bypass (CPB) 24h after administration of study drug or placebo.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Total Avoidance of Transfusions Avoided transfusions	20 Participants	21 Participants
Total Avoidance of Transfusions Had any transfusion	7 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after administration of study drug

Population: The placebo group had one dropout during the study because of a study protocol violation and one patient with missing data at the primary outcome time point (29pt). The fibrinogen group hat three dropouts during the study because of two study protocol violation, one death and one patient with missing data at the primary outcome time point (27pt).

Including Packed Red Cells, Fresh Frozen Plasma, Platelets, Cryoprecipitate and coagulation factor concentrates. The study was not sufficiently powered to test differences between this outcome.

Outcome measures

Measure	RiaSTAP n=27 Participants Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 Participants Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Overall Numbers of Patients Receiving Blood Products	7 Participants	8 Participants

Adverse Events

RiaSTAP

Serious events: 5 serious events

Other events: 1 other events

Deaths: 1 deaths

Intravenous Saline

Serious events: 9 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	RiaSTAP n=27 participants at risk Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 participants at risk Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Surgical and medical procedures Re-Operation	3.7% 1/27 • Number of events 1 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.	13.8% 4/29 • Number of events 4 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.
Nervous system disorders Stroke	3.7% 1/27 • Number of events 1 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.	0.00% 0/29 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.
Psychiatric disorders Postoperative Delirium	7.4% 2/27 • Number of events 2 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.	17.2% 5/29 • Number of events 5 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.
Nervous system disorders Death	3.7% 1/27 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.	0.00% 0/29 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.

Other adverse events

Measure	RiaSTAP n=27 participants at risk Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)	Intravenous Saline n=29 participants at risk Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula Placebo: Intravenous placebo will be infused with the same volume as the study drug.
Skin and subcutaneous tissue disorders Incisional wound infection	3.7% 1/27 • Number of events 1 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.	6.9% 2/29 • Number of events 2 • All study patients were followed with a phone call interview after 6 weeks, 3, and 6 months post-operatively. All patients were assessed for the following events: angina, re-admission (congestive heart failure [CHF], acute myocardial infarction [AMI], acute coronary syndrome [ACS], and percutaneous coronary intervention [PCI]), incisional wound infection, thromboembolic complications (pulmonary embolism, deep venous thrombosis), repeated cardiac surgery, and cardiac mortality.

Additional Information

Dr. Myron Kwapisz

Department of Anesthesia, Dalhousie University, Halifax, Canada

Phone: +1 902 473 4326

Email: myron.kwapisz@nshealth.ca

Results disclosure agreements

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