FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Study Overview
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Brief Summary
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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 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.

Detailed Description
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The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour and 6-month outcome measures include the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 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.

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

Conditions
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Moderate to Severe Traumatic Brain Injury

Intervention / Treatment
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* Biological: Fresh Frozen Plasma (FFP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the ages of 18 and 65 years Moderate to severe TBI: GCS 3-12 Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion ≥ 8 mm ) Exclusion Criteria: Persons with known history of adverse reaction to plasma products. Persons with 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control vs Experimental Biologic Group[
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care Control Group | |
| Experimental: Standard of Care + FFP<br>Standard of Care + Experimental Treatment | Biological: Fresh Frozen Plasma (FFP)<br>* Standard of Care + 2 units (400-500 ml) of fresh frozen plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The first 24 hour post-injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Rating Score (DRS) | Disability Rating Score | Discharge or day 7 of the hospital stay and 6-months post-injury | 
| Correlation | Correlation between Hemorrhagic progression of the contusion (HPC) and Disability Rating Scale (DRS). 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. | 24-hour HPC and 6-month DRS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Traumatic Brain Injury