FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

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.

Conditions

• Moderate to Severe Traumatic Brain Injury

Interventions

BIOLOGICAL

Fresh Frozen Plasma (FFP)

Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Sponsors & Collaborators

• Vanderbilt University Medical Center

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Northwestern University

  lead OTHER

Principal Investigators

• Hasan Alam, MD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-08-31

Completion

2029-06-30

FDA Drug

Yes

Countries

• United States

Study Locations