Phase 3
N=36
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Hemostasis
Bottom Line
View on ClinicalTrials.gov: NCT03932240 ↗Enrolled (actual)
36
Serious AEs
30.6%
Results posted
Mar 2023
Primary outcome: Primary: Clot Degradation at 24 Hours Post-operatively — 0.65; 0.88; 0.78; 0.46 microns per hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrinogen Concentrate (FC) (Drug); Cryoprecipitate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clot Degradation at 24 Hours Post-operatively |
0.65; 0.88; 0.78; 0.46; 0.65; 0.55 | — |
| SECONDARY Clot Strength |
— | — |
| SECONDARY Clot Polymerization Kinetic |
— | — |
| SECONDARY Fibrin Fiber Alignment |
0.46; 0.54; 0.52; 0.54; 0.41; 0.44 | — |
| SECONDARY Interoperative Transfusion Requirement |
27.2; 41.6 | — |
| SECONDARY Transfusion Requirements Within the First 24 Hours After Surgery |
— | — |
| SECONDARY Amount of Post-operative Bleeding |
38.5; 45.5 | — |
| SECONDARY Mechanical Ventilation Time |
63.3; 117.2 | — |
| SECONDARY Length of ICU Stay |
7.0; 8.5 | — |
| SECONDARY Length of Hospital Stay |
16.0; 14.5 | — |
| SECONDARY Number of Adverse Events |
6; 11 | — |
Summary
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.
Eligibility Criteria
Inclusion Criteria
- Full term neonates (36-42 weeks gestational age)
- Infants =< 30 days of age at time of surgery
- APGAR score of 6 or greater at 5 minutes after delivery
- Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta
- Parents willing to participate and able to understand and sign the provided informed consent
Exclusion Criteria
- Preterm neonates (less than 36 weeks gestation)
- Patients undergoing an emergent procedure or surgery not requiring CPB
- Patients with personal or family history of a coagulation defect or coagulopathy
- Parents unwilling to participate or unable to understand and sign the provided informed consent
Data sourced from ClinicalTrials.gov (NCT03932240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.