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

• Status: Completed
• Trial end date: 2021-05-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University

Criteria

Inclusion Criteria:

1. Full term neonates (36-42 weeks gestational age)

2. Infants =< 30 days of age

3. APGAR score of 6 or greater at 5 minutes after delivery

4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta

5. Parents willing to participate and able to understand and sign the provided informed consent

Exclusion Criteria:

1. Preterm neonates (less than 36 weeks gestation)

2. Patients undergoing an emergent procedure or surgery not requiring CPB

3. Patients with personal or family history of a coagulation defect or coagulopathy

4. Parents unwilling to participate or unable to understand and sign the provided informed consent