Trial Outcomes & Findings for In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB) (NCT NCT03932240)

Results Overview

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

36 participants

Primary outcome timeframe

From induction of anesthesia to 24 hours postoperatively

Results posted on

2024-02-20

Participant Flow

Participants were recruited from Children's Healthcare of Atlanta (CHOA) at Egleston in Atlanta, Georgia, USA. Participant enrollment began August 13, 2019 and all follow up was complete by November 16, 2021.

Participant milestones

Participant milestones
Measure	Fibrinogen Concentrate (FC) Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Overall Study STARTED	18	18
Overall Study Completed Study Per Protocol	17	13
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	14 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Weight	3.10 kilograms (kg) n=93 Participants	3.50 kilograms (kg) n=4 Participants	3.40 kilograms (kg) n=27 Participants

PRIMARY outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population, which is comprised on all participants regardless of if they completed the study per protocol.

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Clot Degradation at 24 Hours Post-operatively After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.78 microns per hour Interval 0.33 to 0.92	0.46 microns per hour Interval 0.27 to 1.56
Clot Degradation at 24 Hours Post-operatively Upon arrival to the ICU	0.65 microns per hour Interval 0.44 to 0.88	0.55 microns per hour Interval 0.28 to 2.39
Clot Degradation at 24 Hours Post-operatively 24 hours post-operatively	0.92 microns per hour Interval 0.55 to 1.42	0.76 microns per hour Interval 0.34 to 1.22
Clot Degradation at 24 Hours Post-operatively After induction of anesthesia prior to CPB	0.65 microns per hour Interval 0.41 to 1.49	0.88 microns per hour Interval 0.37 to 1.42

SECONDARY outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: Unfortunately, due to the required amount of blood necessary for triplicates of the primary outcome, there was not enough blood to examine clot strength. Due to the small amount of blood collected from neonates the samples were used for the outcome measures with the highest priority and the amount of remaining blood was not sufficient to assess clot strength.

Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: Due to the maximum allowable blood to be taken from a neonate, there was not enough remaining blood available to examine clot polymerization kinetics. In order to carry out the degradation assay on neonatal fibrinogen, the study team improved the assay they originally intended to use and no longer did polymerization assays as part of the degradation assay. Due to the change in the degradation assay, the team was not able to collect additional blood for the clot polymerization kinetics assay.

Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Fibrin Fiber Alignment After induction of anesthesia prior to CPB	0.46 black/white pixels Interval 0.26 to 0.61	0.54 black/white pixels Interval 0.32 to 0.68
Fibrin Fiber Alignment 24 hours post-operatively	0.37 black/white pixels Interval 0.15 to 0.52	0.38 black/white pixels Interval 0.1 to 0.58
Fibrin Fiber Alignment After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.52 black/white pixels Interval 0.37 to 0.59	0.54 black/white pixels Interval 0.45 to 0.63
Fibrin Fiber Alignment Upon arrival to the ICU	0.41 black/white pixels Interval 0.31 to 0.58	0.44 black/white pixels Interval 0.37 to 0.66

SECONDARY outcome

Timeframe: During surgery (up to 6 hours)

Population: This analysis includes the Intent to Treat Population.

Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Interoperative Transfusion Requirement	27.2 ml/kg Interval 19.0 to 36.9	41.6 ml/kg Interval 29.2 to 52.4

SECONDARY outcome

Timeframe: 24 hours postoperatively

Population: The recording of transfusions in the intensive care unit (ICU) changed in the middle of this study and therefore transfusions were not consistently documented by the clinical staff, thus, the study investigators decided to not collect information about transfusions up to 24 hours after surgery from medical records as data could not be reliably analyzed.

Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Amount of Post-operative Bleeding	38.5 ml/kg Interval 32.0 to 70.5	45.5 ml/kg Interval 31.5 to 69.0

SECONDARY outcome

Timeframe: Time of extubation (up to 2 weeks)

Population: This analysis includes the Intent to Treat Population.

Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Mechanical Ventilation Time	63.3 hours Interval 35.6 to 77.9	117.2 hours Interval 39.9 to 168.0

SECONDARY outcome

Timeframe: At discharge from ICU (typically up to 21 days)

Population: This analysis includes the Intent to Treat Population.

Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Length of ICU Stay	7.0 days Interval 5.0 to 14.0	8.5 days Interval 5.3 to 13.3

SECONDARY outcome

Timeframe: At discharge from hospital (up to 150 days)

Population: This analysis includes the Intent to Treat Population.

Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Length of Hospital Stay	16.0 days Interval 10.8 to 47.5	14.5 days Interval 9.5 to 29.8

SECONDARY outcome

Timeframe: Within seven days of surgery

Population: This analysis includes the Intent to Treat Population.

Adverse events within seven days of surgery were obtained from medical records.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Number of Adverse Events	6 adverse events	11 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Within the first 24 hours of surgery

Population: This analysis includes the Intent to Treat Population.

The number of events of clinically significant postoperative thrombosis that required treatment were obtained from medical records.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Number of Events of Postoperative Thrombosis	2 events	2 events

OTHER_PRE_SPECIFIED outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Normal fibrinogen plasma values are between 0.5 to 15 mcg/mL.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Fibrinogen Plasma Level Within 2 hours of induction of anesthesia prior to CPB	1.39 mcg/mL Interval 0.99 to 2.11	1.09 mcg/mL Interval 0.75 to 2.2
Fibrinogen Plasma Level 24 hours post-operatively	1.76 mcg/mL Interval 1.49 to 2.11	1.87 mcg/mL Interval 1.43 to 2.27
Fibrinogen Plasma Level After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	1.26 mcg/mL Interval 0.99 to 1.57	1.97 mcg/mL Interval 1.12 to 2.82
Fibrinogen Plasma Level Upon arrival to the ICU	1.42 mcg/mL Interval 1.08 to 2.22	1.28 mcg/mL Interval 1.07 to 1.69

OTHER_PRE_SPECIFIED outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for thrombin plasma level is 0.000313 to 0.02 mcg/mL.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Thrombin Plasma Level Within 2 hours of induction of anesthesia prior to CPB	0.02 mcg/mL Interval 0.01 to 0.06	0.07 mcg/mL Interval 0.02 to 0.1
Thrombin Plasma Level After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.02 mcg/mL Interval 0.01 to 0.05	0.05 mcg/mL Interval 0.03 to 0.06
Thrombin Plasma Level 24 hours post-operatively	0.02 mcg/mL Interval 0.01 to 0.08	0.06 mcg/mL Interval 0.03 to 0.08
Thrombin Plasma Level Upon arrival to the ICU	0.03 mcg/mL Interval 0.02 to 0.06	0.05 mcg/mL Interval 0.03 to 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for FXIII plasma level is 0.000469 to 0.03 mcg/mL.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
FXIII Plasma Level Within 2 hours of induction of anesthesia prior to CPB	0.03 mcg/mL Interval 0.03 to 0.06	0.03 mcg/mL Interval 0.03 to 0.04
FXIII Plasma Level After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	0.04 mcg/mL Interval 0.02 to 0.05	0.04 mcg/mL Interval 0.03 to 0.07
FXIII Plasma Level Upon arrival to the ICU	0.04 mcg/mL Interval 0.03 to 0.06	0.05 mcg/mL Interval 0.04 to 0.07
FXIII Plasma Level 24 hours post-operatively	0.03 mcg/mL Interval 0.03 to 0.04	0.04 mcg/mL Interval 0.03 to 0.05

OTHER_PRE_SPECIFIED outcome

Timeframe: From induction of anesthesia to 24 hours postoperatively

Population: This analysis includes the Intent to Treat Population.

Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Lower values may indicate an increased risk of excessive bleeding.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentrate (FC) n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 Participants Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Von Willebrand Factor Plasma Level After termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen	4.43 IU/mL Interval 3.48 to 15.56	6.11 IU/mL Interval 5.42 to 16.37
Von Willebrand Factor Plasma Level Upon arrival to the ICU	5.06 IU/mL Interval 3.43 to 7.16	6.15 IU/mL Interval 5.53 to 12.81
Von Willebrand Factor Plasma Level 24 hours post-operatively	3.95 IU/mL Interval 3.35 to 12.75	7.00 IU/mL Interval 4.78 to 11.73
Von Willebrand Factor Plasma Level Within 2 hours of induction of anesthesia prior to CPB	2.98 IU/mL Interval 1.86 to 7.01	4.68 IU/mL Interval 1.75 to 6.56

Adverse Events

Fibrinogen Concentrate (FC)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Cryoprecipitate

Serious events: 9 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Fibrinogen Concentrate (FC) n=18 participants at risk Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 participants at risk Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Surgical and medical procedures Extracorporeal membrane oxygenation (ECMO) within 24 hours	0.00% 0/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	22.2% 4/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Surgical and medical procedures Tamponade	0.00% 0/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	5.6% 1/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Surgical and medical procedures Chest exploration	5.6% 1/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	11.1% 2/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Vascular disorders Stroke	5.6% 1/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	0.00% 0/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Infections and infestations Infection	0.00% 0/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	11.1% 2/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).

Other adverse events

Other adverse events
Measure	Fibrinogen Concentrate (FC) n=18 participants at risk Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass.	Cryoprecipitate n=18 participants at risk Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass.
Cardiac disorders Arrhythmia	11.1% 2/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	22.2% 4/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Vascular disorders Thrombosis	11.1% 2/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).	11.1% 2/18 • Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).

Additional Information

Laura Downey, MD

Emory University

Phone: 404-785-6670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place