FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

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.

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	Moderate to Severe Traumatic Brain Injury
Enrollment	357 participants
Start Date	2026-02-01
Primary Completion	2028-08 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-02-11