FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorthwestern University
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fresh Frozen Plasma (FFP)
Treatment groups
357 Participants
are divided into 2 treatment groupsSponsors and collaborators
Northwestern University
Lead sponsor
Vanderbilt University Medical Center
Collaborator
University of Southern California
Collaborator
Oregon Health and Science University
Collaborator
Medical College of Wisconsin
Collaborator
University of Texas Southwestern Medical Center
Collaborator
University of California, Davis
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov