NCT06062888 · Northwestern University
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
What this study 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Fresh Frozen Plasma (FFP)
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
Primary outcome measures
Extended Glasgow Outcome Scale (GOS-E)
Time frame: 3 months
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Chicago, Illinois
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
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations