FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
Northwestern University
357 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
Exclusion Criteria13
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06062888