FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Conditions

• Moderate to Severe Traumatic Brain Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Fresh Frozen Plasma (FFP) — BIOLOGICAL
  Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Study Details

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.

Key Dates

Start date

Feb 1, 2026

Status verified

Feb 2026

Primary completion

Aug 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

357 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard of Care
  Standard of Care Control Group
• Experimental: Standard of Care + FFP
  Standard of Care + Experimental Treatment

Primary Outcome Measure

Extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 3 months ]

Central Contacts

• Hasan Alam, MD
  312-926-4962
  [email protected]
• Nicole Meredyth, MD
  312-694-4867
  [email protected]

Locations (1)

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