Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage

Not yet recruitingOBSERVATIONAL
Enrollment

320

Participants

Timeline

Start Date

May 31, 2026

Primary Completion Date

February 29, 2028

Study Completion Date

August 31, 2028

Conditions
HypofibrinogenemiaHemorrhage
Interventions
BIOLOGICAL

Pathogen Reduced Cryoprecipitated Fibrinogen Complex

IFC will be administered based on the study site's assigned treatment block. Study subjects will receive IFC with a point-of-care testing value of FCS \<1.6 hPa. Additional IFC may be administered per point-of-care testing or clinical judgement, as needed.

BIOLOGICAL

Cryoprecipitated-Antihemophilic Factor

Cryo-AHF will be administered based on the study site's assigned treatment block. Study subjects will receive Cryo-AHF with a point-of-care testing value of FCS \<1.6 hPa. Additional Cryo-AHF may be administered per point-of-care testing or clinical judgement, as needed.

Trial Locations (4)

21021

University of Maryland School of Medicine, Baltimore

33136

Jackson Memorial Hospital, University of Miami, Miami

63110

Barnes-Jewish Hospital, Washington University of Saint Louis, St Louis

80045

University of Colorado, Anschutz Medical Center, Aurora

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Coalition for National Trauma Research

OTHER

lead

Cerus Corporation

INDUSTRY

NCT07218185 - Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage | Biotech Hunter | Biotech Hunter