FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

ConditionModerate to Severe Traumatic Brain Injury

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Fresh Frozen Plasma (FFP)
Biological/Vaccine
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Treatment groups

357 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Standard of Care + FFPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Extended Glasgow Outcome Scale (GOS-E)

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.

Time frame

3 months

Secondary outcomes

Hemorrhagic progression of the contusion (HPC)

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.

Time frame

The first 24 hour post-injury

Disability Rating Scale (DRS)

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.

Time frame

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

Other outcomes

Disability Rating Scale (DRS)

Time frame

6 months post-injury

Extended Glasgow Outcome Scale (GOS-E)

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.

Time frame

6 months post-injury

Time to treatment

Time to treatment measured in hours and minutes.

Time frame

The first 24 hours post-injury

Contusion volume

Total contusion volume measured in mm3

Time frame

The first 24 hours post-injury

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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