Status:
RECRUITING
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Vanderbilt University Medical Center
University of Southern California
Conditions:
Moderate to Severe Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ar...
Detailed Description
The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT s...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion ≥ 8 mm )
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
Exclusion
- Persons with a known history of adverse reaction to plasma products.
- Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
- Persons who are currently incarcerated.
- Persons with inadequate venous access.
- Treatment cannot start within 1 hour of arrival at the hospital.
- The time of injury is unknown.
- Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
- Interfacility transfers
- Class 3 hemorrhagic shock
- Persons with known "do not resuscitate" orders prior to randomization
- Persons who refuse the administration of blood products
- Persons with a research "opt out" bracelet
- Persons who require FFP for any other indication (e.g., reversal of coagulopathy)
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT06062888
Start Date
October 1 2025
End Date
June 1 2029
Last Update
September 4 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611