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Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage
Sponsor: Cerus Corporation
Summary
The objective of this study is to determine the feasibility and effectiveness of early IFC administration in patients with functional hypofibrinogenemia associated with hemorrhagic shock (HS). This study will elucidate whether advancements in rapid testing for functional hypofibrinogenemia and provision of a shelf-stable fibrinogen complex (IFC) results in a shorter time to administration of fibrinogen replacement, thus overcoming the limitations encountered by prior trials. This study aims to: * Demonstrate the feasibility and response to early administration of pre-thawed IFC compared to CRYO-AHF when ordered during resuscitation of severely injured patients with HS and functional hypofibrinogenemia. * Assess effectiveness of early administration of pre-thawed IFC vs CRYO-AHF in severely injured patients with HS and functional hypofibrinogenemia on proximate process measures of resuscitation. * Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC vs CRYO-AHF product.
Official title: Comparative Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage: CRYO-FIRST, A Quality Improvement Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
320
Start Date
2026-05
Completion Date
2028-08
Last Updated
2025-10-20
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (4)
University of Colorado, Anschutz Medical Center
Aurora, Colorado, United States
Jackson Memorial Hospital, University of Miami
Miami, Florida, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Barnes-Jewish Hospital, Washington University of Saint Louis
St Louis, Missouri, United States