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

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 13, 2019

Primary Completion Date

April 9, 2021

Study Completion Date

November 16, 2021

Conditions
Hemostasis
Interventions
DRUG

Fibrinogen Concentrate (FC)

The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.

DRUG

Cryoprecipitate

The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.

Trial Locations (1)

30322

Children's Healthcare of Atlanta (CHOA), Egleston, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT03932240 - In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB) | Biotech Hunter | Biotech Hunter