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FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Primary Purpose

Moderate to Severe Traumatic Brain Injury

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fresh Frozen Plasma (FFP)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Traumatic Brain Injury focused on measuring TBI, Traumatic Brain Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard of Care

    Standard of Care + FFP

    Arm Description

    Standard of Care Control Group

    Standard of Care + Experimental Treatment

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Disability Rating Score (DRS)
    Disability Rating Score
    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.

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Northwestern University
    Collaborators
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062888
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    March 2027 (Anticipated)
    Study Completion Date
    September 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Traumatic Brain Injury
    Keywords
    TBI, Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Control vs Experimental Biologic Group[
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    264 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    Standard of Care Control Group
    Arm Title
    Standard of Care + FFP
    Arm Type
    Experimental
    Arm Description
    Standard of Care + Experimental Treatment
    Intervention Type
    Biological
    Intervention Name(s)
    Fresh Frozen Plasma (FFP)
    Intervention Description
    Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
    Primary Outcome Measure Information:
    Title
    Hemorrhagic progression of the contusion (HPC)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Disability Rating Score (DRS)
    Description
    Disability Rating Score
    Time Frame
    Discharge or day 7 of the hospital stay and 6-months post-injury
    Title
    Correlation
    Description
    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.
    Time Frame
    24-hour HPC and 6-month DRS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hasan Alam, MD
    Phone
    312-926-4962
    Email
    Hasan.Alam@nm.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leah Tatebe, MD
    Phone
    312-694-8010
    Email
    LTatebe@nm.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hasan Alam, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35343931
    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.
    Results Reference
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    FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

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