Status:
NOT_YET_RECRUITING
Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage
Lead Sponsor:
Cerus Corporation
Collaborating Sponsors:
Coalition for National Trauma Research
Conditions:
Hypofibrinogenemia
Hemorrhage
Eligibility:
All Genders
18+ years
Brief 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 st...
Detailed Description
This study is a multicenter, multi-period, by hospital cluster randomized, alternating treatment block crossover study comparing pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERC...
Eligibility Criteria
Inclusion
- Traumatic injury
- Age ≥18 years or estimated weight ≥ 50 kg, if age unknown
- Presenting to participating trauma center ≤1 hour from estimated time of injury
- Functional hypofibrinogenemia upon arrival to the trauma center as measured by POC testing (Quantra) with an FCS \< 1.6 hPa
- Hemorrhagic shock defined as:
- Initiation of transfusion of any uncross matched blood product AND
- Evidence of active hemorrhage as judged by the attending trauma surgeon AND
- Initiation of the participating trauma center's MTP
- IFC or CRYO-AHF are available at the time of enrollment.
Exclusion
- Suspected isolated severe brain or spinal cord injury
- Isolated drowning or hanging
- Burns \> 20% total body surface area (TBSA)
- Known pregnancy
- Admitted from a correctional facility
- Known do not resuscitate (DNR) order
- Traumatic arrest \>5 minutes
- Isolated fall from standing
- Emergency Department (ED) thoracotomy
Key Trial Info
Start Date :
May 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT07218185
Start Date
May 1 2026
End Date
August 1 2028
Last Update
October 17 2025
Active Locations (4)
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1
University of Colorado, Anschutz Medical Center
Aurora, Colorado, United States, 80045
2
Jackson Memorial Hospital, University of Miami
Miami, Florida, United States, 33136
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21021
4
Barnes-Jewish Hospital, Washington University of Saint Louis
St Louis, Missouri, United States, 63110