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FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Sponsor: Northwestern University
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.
Official title: Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
357
Start Date
2026-02-01
Completion Date
2029-06
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Fresh Frozen Plasma (FFP)
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
Locations (1)
Northwestern University
Chicago, Illinois, United States