drugset / Trial / NCT03932240

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

NCT03932240

Phase 3 Completed 36 enrolled Emory University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2019-08-13
Primary completion
2021-04-09
Completion
2021-11-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cryoprecipitate Protein / enzyme biologic 2 unknown
Subject Fibrinogen Concentrate Human Protein / enzyme biologic