RECRUITING

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-10
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06062888

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female between the ages of 18 and 65 years
  2. 2. Moderate to severe TBI: GCS 3-12
  3. 3. Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion ≥ 8 mm )
  4. 4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
  1. 1. Persons with a known history of adverse reaction to plasma products.
  2. 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. 3. Persons who are currently incarcerated.
  4. 4. Persons with inadequate venous access.
  5. 5. Treatment cannot start within 1 hour of arrival at the hospital.
  6. 6. The time of injury is unknown.
  7. 7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
  8. 8. Interfacility transfers
  9. 9. Class 3 hemorrhagic shock
  10. 10. Persons with known "do not resuscitate" orders prior to randomization
  11. 11. Persons who refuse the administration of blood products
  12. 12. Persons with a research "opt out" bracelet
  13. 13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)

Contacts and Locations

Study Contact

Hasan Alam, MD
CONTACT
312-926-4962
Hasan.Alam@nm.org
Nicole Meredyth, MD
CONTACT
312-694-4867
nicole.meredyth@nm.org

Principal Investigator

Hasan Alam, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Hasan Alam, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-10
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • TBI
  • Traumatic Brain Injury
  • Fresh frozen plasma
  • FFP

Additional Relevant MeSH Terms

  • Moderate to Severe Traumatic Brain Injury