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FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06062888
Collaborator
Vanderbilt University Medical Center (Other), University of Southern California (Other), Oregon Health and Science University (Other), Medical College of Wisconsin (Other), University of Texas Southwestern Medical Center (Other), University of California, Davis (Other), University of Alabama at Birmingham (Other)
264
Enrollment
2
Arms
42
Anticipated Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Fresh Frozen Plasma (FFP)
 Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control vs Experimental Biologic Group[Control vs Experimental Biologic Group[
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Standard of Care Control Group
Experimental: Standard of Care + FFP

Standard of Care + Experimental Treatment

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

Outcome Measures

Primary Outcome Measures

  1. Hemorrhagic progression of the contusion (HPC) [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.

Secondary Outcome Measures

  1. Disability Rating Score (DRS) [Discharge or day 7 of the hospital stay and 6-months post-injury]

    Disability Rating Score

  2. Correlation [24-hour HPC and 6-month DRS]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 known history of adverse reaction to plasma products.

  2. Persons with 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Hasan Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hasan Alam, Chair, Department of Surgery, Northwestern University
ClinicalTrials.gov Identifier:
NCT06062888
Other Study ID Numbers:
  • STU00218211
  • W81XWH2211106
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hasan Alam, Chair, Department of Surgery, Northwestern University
TBI
Traumatic Brain Injury
Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries

Study Results

No Results Posted as of Oct 2, 2023