Trial Outcomes & Findings for Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients (NCT NCT04376762)
NCT ID: NCT04376762
Last Updated: 2026-03-06
Results Overview
comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
Fibrinogen Concentrate
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Fibrinogen Concentrate
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Overall Study
No bleeding after cardiopulmonary bypass (CPB)
|
3
|
0
|
|
Overall Study
Avoidance of CPB
|
1
|
0
|
|
Overall Study
No evidence of hypofibrinogenemia
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fibrinogen Concentrate
n=15 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
18 Participants
n=30 Participants
|
|
Age, Categorical
<=18 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
4.6 months
STANDARD_DEVIATION 3.7 • n=15 Participants
|
5.2 months
STANDARD_DEVIATION 5.1 • n=15 Participants
|
4.9 months
STANDARD_DEVIATION 4.39 • n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
12 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
26 participants
n=30 Participants
|
|
Weight
|
5.8 kg
STANDARD_DEVIATION 2.1 • n=15 Participants
|
5.3 kg
STANDARD_DEVIATION 1.7 • n=15 Participants
|
5.55 kg
STANDARD_DEVIATION 1.89 • n=30 Participants
|
PRIMARY outcome
Timeframe: from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unitcomparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery
|
3.4 allogeneic blood products
Interval 2.0 to 6.0
|
4.5 allogeneic blood products
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU(intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml)
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Comparison of Post CPB Bleeding (in ml) Between the Study Groups
|
48.7 mL
Interval 35.0 to 81.0
|
46.2 mL
Interval 30.0 to 73.0
|
SECONDARY outcome
Timeframe: From immediately after study medication administration through postoperative day 7Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
|
0 RBC units
Interval 0.0 to 0.0
|
0 RBC units
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From immediately after study medication administration through postoperative day 7Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
|
1 platelets units
Interval 1.0 to 1.0
|
1 platelets units
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: From immediately after study medication administration through postoperative day 7Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
|
0 plasma units
Interval 0.0 to 0.0
|
0 plasma units
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From immediately after study medication administration through postoperative day 7Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7
|
0 additional cryoprecipitate units
Interval 0.0 to 0.0
|
0 additional cryoprecipitate units
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: from admission to the ICU until postoperative day 7Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from separation from CPB until 48 hours after surgerycomparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Incidence of the Use of Factor VIIa for Bleeding
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)comparison of the incidence of in-hospital mortality between the study groups
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
In-hospital Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from admission to the ICU until postoperative day 7comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome)
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Post Operative Acute Kidney Injury (AKI)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Postoperative Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from admission to the ICU until POD 7Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Percent of Patients With Postoperative Neurological Injury
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)Population: Protocol was amended (as of 3-30-2020 prior to first enrollment on 10-27-2021) to not assess this Secondary Outcome Measure. Thus, no data on intubation time was collected.
comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups
Outcome measures
| Measure |
Fibrinogen Concentrate
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Intubation Time
|
NA (NUMBER)
|
NA (NUMBER)
|
SECONDARY outcome
Timeframe: from admission to the ICU until 7 days postoperativelycomparison of the incidence of DVT/PE/shunt thrombosis between the study groups
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Postoperative Thromboembolic Event
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)comparison of the postoperative time period spent in the ICU
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
ICU Length of Stay
|
15.2 days
Standard Deviation 19.1
|
10.5 days
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital
Outcome measures
| Measure |
Fibrinogen Concentrate
n=11 Participants
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 Participants
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Hospital Length of Stay
|
23.8 days
Standard Deviation 27
|
15.5 days
Standard Deviation 16.4
|
Adverse Events
Fibrinogen Concentrate
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cryoprecipitate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fibrinogen Concentrate
n=11 participants at risk
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 participants at risk
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
0.00%
0/15 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
|
Cardiac disorders
Cardioversion
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
0.00%
0/15 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
Other adverse events
| Measure |
Fibrinogen Concentrate
n=11 participants at risk
Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Fibrinogen: Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
Cryoprecipitate
n=15 participants at risk
. Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
|
|---|---|---|
|
Nervous system disorders
Seizure/Stroke
|
0.00%
0/11 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
|
Cardiac disorders
Internal Chest Compressions and Pacing
|
0.00%
0/11 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place