Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for 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
  • Hemorrhagic Shock
  • Hypofibrinogenemia
  • Trauma Associated Hemorrhage

Eligibility Criteria

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

Interventions

  • Pathogen Reduced Cryoprecipitated Fibrinogen Complex — BIOLOGICAL
    Pre-thawed IFC will be administered per standard of care when cryoprecipitate administration is clinically indicated by the treating physician and IFC is available. Participants must have functional hypofibrinogenemia by Quantra® POC testing with FCS \<1.6 hPA. Additional IFC may be administered based on repeat POC testing or clinical judgment.

Study Details

The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF). This study aims to: * Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia. * Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation. * Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 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.

Primary Outcome Measure

IFC administration within 60 minutes of presentation [ Time Frame: From presentation/admission to the participating trauma center to initial IFC transfusion, assessed up to 60 minutes after presentation. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Anschutz Medical Center, University of ColoradoAuroraColorado80045
Mitchell Cohen, MD
[email protected]
303-602-1861
Ryder Trauma Center/Jackson Memorial Hospital, University of MiamiMiamiFlorida33136
Jonathan Meizoso, MD, MSPH
[email protected]
303-585-1178
R Adams Cowley Shock Trauma Center, University of MarylandBaltimoreMaryland21201
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
Anschutz Medical Center, University of Colorado· Aurora, CORyder Trauma Center/Jackson Memorial Hospital, University of Miami· Miami, FLR Adams Cowley Shock Trauma Center, University of Maryland· Baltimore, MDBarnes Jewish Hospital, Washington University of Saint Louis· St Louis, MO

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