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FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Start date changed from estimate of Oct 2025 to Feb 1, 2026
    • Eligibility criteria shortened, about 2 words
    v8
  2. Trial status: Not Yet Recruiting to Recruitingv7 Show 6 more changesShow less
    • Start date: Apr 15, 2025 to Oct 2025
    • Study sites: 0 to 1
    • Primary completion date: Feb 2028 to Aug 2028
    • Study completion date: Sep 2028 to Jun 2029
    • Eligibility criteria expanded, about 20 words
    • Publications: 2 to 3
  3. Start date: Jan 15, 2025 to Apr 15, 2025v6
  4. Primary completion date: Mar 2027 to Feb 2028
    • Start date: Aug 2024 to Jan 15, 2025
    • Enrollment target: 264 to 357
    • Study completion date: Sep 2027 to Sep 2028
    v5
  5. Start date: Apr 2024 to Aug 2024v4
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  1. Re-verified, no change to tracked fieldsv3
  2. Primary endpoint revisedv2 Show 4 more changesShow less
    • Start date: Mar 2024 to Apr 2024
    • Secondary endpoints revised (2)
    • Study description expanded, about 14 words
    • Eligibility criteria expanded, about 2 words
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question\[s\]it aims to answer are: * Is the FFP treatment safe? * Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either: * Standard of care treatment * Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.
Trial Details
NCT Number NCT06062888
Lead Sponsor Northwestern University
Collaborators: Vanderbilt University Medical Center, University of Southern California, Oregon Health and Science University, Medical College of Wisconsin, University of Texas Southwestern Medical Center, University of California, Davis, University of Alabama at Birmingham
Conditions
(from sponsor)		 Moderate to Severe Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 357 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov