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

Study acronym: CRYO-FIRST
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Enrolling by invitation only Show 6 more changesShow less
    • Start date changed from estimate of Jul 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised at 4 of 4 sites
    • Publications: details revised at 6 of 7 entries
  2. Start date: May 2026 to Jul 2026v2 Show 10 more changesShow less
    • Primary endpoints revised (2)
    • Primary completion date: Feb 2028 to Jul 2028
    • Interventions: Cryoprecipitated-Antihemophilic Factor (Biological), Pathogen Reduced Cryoprecipitated Fibrinogen Complex (Biological) to Pathogen Reduced Cryoprecipitated Fibrinogen Complex (Biological)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 10 words
    • Study sites revised (4)
    • Publications: details revised at 7 of 7 entries
    • Study title shortened, about 6 words
    • Study arms: 2 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07218185
Lead Sponsor Cerus Corporation
Collaborators: Coalition for National Trauma Research
Conditions
(from sponsor)		 Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
Related terms Afibrinogenemia, Hemorrhage, Shock, Hemorrhagic, Wounds and Injuries
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov