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NCT Number: NCT06062888

FFP In Traumatic BRAin INjury (FIT-BRAIN) 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.

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Key information

Conditions

Moderate to Severe Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Nicole Meredyth, MD

CONTACT

[email protected]

312-694-4867

About this study

The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E).

A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fresh frozen plasma (FFP)

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hemorrhagic progression of the contusion (HPC)

    Time frame: The first 24 hour post-injury

    We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan.

  2. Disability Rating Scale (DRS)

    Time frame: Discharge or day 7 of the hospital stay and 3 months post-injury

    This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.

Other outcomes

  1. Disability Rating Scale (DRS)

    Time frame: 6 months post-injury

    This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.

  2. Extended Glasgow Outcome Scale (GOS-E)

    Time frame: 6 months post-injury

    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.

  3. Time to treatment

    Time frame: The first 24 hours post-injury

    Time to treatment measured in hours and minutes.

  4. Contusion volume

    Time frame: The first 24 hours post-injury

    Total contusion volume measured in mm3

  5. Non-contiguous contusions

    Time frame: The first 24 hours post-injury

    Count of non-contiguous contusions

  6. Glasgow Coma Scale (GCS)

    Time frame: The first 24 hours post-injury

    This scale uses three behavior categories to measure response with larger numbers and total score representing a better outcome. They are: Eye opening response (4-1), Best verbal response (5-1) and Best motor response (6-1). Of the total score 15=Best response, 8 or less = Comatose client and 3=Totally unresponsive.

  7. TBI severity sub-stratification using the Glasgow Coma Scale (GCS)

    Time frame: The first 24 hours post-injury

    his scale uses three behavior categories to measure response with larger numbers and total score representing a better outcome. They are: Eye opening response (4-1), Best verbal response (5-1) and Best motor response (6-1). Of the total score 15=Best response, 8 or less = Comatose client and 3=Totally unresponsive. (GCS 9-12) = moderate and (GCS 3-8)=severe

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan Alam, MD

CONTACT

[email protected]

312-926-4962

Nicole Meredyth, MD

CONTACT

[email protected]

312-694-4867

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Medical College of Wisconsin
  • Oregon Health and Science University
  • University of Alabama at Birmingham
  • University of California, Davis
  • University of Southern California
  • University of Texas Southwestern Medical Center
  • Vanderbilt University Medical Center

Registry information

Official study title

Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Oct 2, 2023
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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