RECRUITING

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Description

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.

Conditions

Moderate to Severe Traumatic Brain Injury
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Related Conditions:

Moderate to Severe Traumatic Brain Injury

Study Overview

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Study Details

Study 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.

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

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Condition
Moderate to Severe Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 )
  • 4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
  • 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Hasan Alam, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2029-06