Actively Recruiting
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Led by Northwestern University · Updated on 2026-02-11
357
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: Glasgow Coma Scale score 3-12
- Confirmed cerebral trauma on initial CT scan meeting Brain Injury Guidelines category 3 (BIG 3)
- No power of attorney related to blood product administration found in participant's wallet when present
You will not qualify if you...
- Known history of adverse reaction to plasma products
- Known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home oxygen
- Currently incarcerated
- Inadequate venous access
- Treatment cannot start within 1 hour of hospital arrival
- Unknown time of injury
- Non-survivable injuries as estimated by trauma or neurosurgeon
- Interfacility transfers
- Class 3 hemorrhagic shock
- Known do not resuscitate orders prior to randomization
- Refusal of blood product administration
- Research opt-out bracelet
- Need for FFP for other indications such as reversal of coagulopathy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
H
Hasan Alam, MD
CONTACT
N
Nicole Meredyth, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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