Clinical trial NCT06062888: FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Official title: Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Moderate to Severe Traumatic Brain Injury
Keywords: TBI
Traumatic Brain Injury
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: University of Southern California
name: Oregon Health and Science University
name: Medical College of Wisconsin
name: University of Texas Southwestern Medical Center
name: University of California, Davis
name: University of Alabama at Birmingham
First posted: 2023-10-02
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control vs Experimental Biologic Group
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 65 years
2. Moderate to severe TBI: GCS 3-12
3. Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion ≥ 8 mm )

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)

Primary outcomes:
measure: Extended Glasgow Outcome Scale (GOS-E)
timeFrame: 3 months
Secondary outcomes:
measure: Hemorrhagic progression of the contusion (HPC)
timeFrame: The first 24 hour post-injury
measure: Disability Rating Scale (DRS)
timeFrame: Discharge or day 7 of the hospital stay and 3 months post-injury
Other outcomes:
measure: Disability Rating Scale (DRS)
timeFrame: 6 months post-injury
measure: Extended Glasgow Outcome Scale (GOS-E)
timeFrame: 6 months post-injury
measure: Time to treatment
timeFrame: The first 24 hours post-injury
measure: Contusion volume
timeFrame: The first 24 hours post-injury
measure: Non-contiguous contusions
timeFrame: The first 24 hours post-injury
measure: Glasgow Coma Scale (GCS)
timeFrame: The first 24 hours post-injury
measure: TBI severity sub-stratification using the Glasgow Coma Scale (GCS)
timeFrame: The first 24 hours post-injury
Locations:
Study officials:
affiliation: Northwestern University
name: Hasan Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joseph B, Obaid O, Dultz L, Black G, Campbell M, Berndtson AE, Costantini T, Kerwin A, Skarupa D, Burruss S, Delgado L, Gomez M, Mederos DR, Winfield R, Cullinane D; AAST BIG Multi-institutional Study Group. Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial. J Trauma Acute Care Surg. 2022 Aug 1;93(2):157-165. doi: 10.1097/TA.0000000000003554. Epub 2022 Mar 28.