Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 26, 2021

Primary Completion Date

March 1, 2023

Study Completion Date

May 1, 2023

Conditions
Pediatric HDBleeding
Interventions
DRUG

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).

DRUG

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).

Trial Locations (1)

22908

University of Virginia Health System, Charlottesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Octapharma

INDUSTRY

lead

University of Virginia

OTHER

NCT04376762 - Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients | Biotech Hunter | Biotech Hunter