FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Phase 3RecruitingNCT06062888

Northwestern University357 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

357

Conditions

Moderate to Severe Traumatic Brain Injury

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female between the ages of 18 and 65 years 2. Moderate to severe TBI: GCS 3-12 3. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3). 4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified. Exclusion Criteria: 1. Persons with a known history of adverse reaction to plasma products. 2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen. 3. Persons who are currently incarcerated. 4. Persons with inadequate venous access. 5. Treatment cannot start within 1 hour of arrival at the hospital. 6. The time of injury is unknown. 7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon. 8. Interfacility transfers 9. Class 3 hemorrhagic shock 10. Persons with known "do not resuscitate" orders prior to randomization 11. Persons who refuse the administration of blood products 12. Persons with a research "opt out" bracelet 13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)

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