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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Cerus Corporation
Study ID
NCT07218185
Status
Not Yet Recruiting

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Conditions

  • Hemorrhage
  • Hypofibrinogenemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pathogen Reduced Cryoprecipitated Fibrinogen Complex — BIOLOGICAL
    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 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Oct 2025
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
320 participants (estimated)

Arms

  • Arm: IFC arm
    Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.
  • Arm: Cryo AHF arm
    Subjects will receive Cryoprecipitated-Antihemophilic Factor (Cryo-AHF) for fibrinogen supplementation.

Primary Outcome Measure

Correction of functional fibrinogen [ Time Frame: From time of initiation of anesthesia until time of completion of resuscitation. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado, Anschutz Medical CenterAuroraColorado80045
Mitchell Cohen, MD
[email protected]
303-602-1861
Jackson Memorial Hospital, University of MiamiMiamiFlorida33136
Jonathan Meizoso, MD, MSPH
[email protected]
303-585-1178
University of Maryland School of MedicineBaltimoreMaryland21021
Deborah M Stein, MD, MPH
[email protected]
410-328-3495
Rosemary Kozar, MD, PhD
[email protected]
410-328-3495
Barnes-Jewish Hospital, Washington University of Saint LouisSt LouisMissouri63110
Grant Bochicchio, MD, MPH
[email protected]
314-747-2829

Find similar trials in Aurora, CO

By research site
University of Colorado, Anschutz Medical Center· Aurora, COJackson Memorial Hospital, University of Miami· Miami, FLUniversity of Maryland School of Medicine· Baltimore, MDBarnes-Jewish Hospital, Washington University of Saint Louis· St Louis, MO

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