FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Launched by NORTHWESTERN UNIVERSITY · Sep 25, 2023

Keywords

ClinConnect Summary

The FIT-BRAIN Trial is a research study looking at how fresh frozen plasma (FFP) treatment can help people who have moderate to severe traumatic brain injuries (TBI). The main goals of this trial are to find out whether the FFP treatment is safe and if it can improve recovery outcomes for patients after 24 hours, 3 months, and 6 months. Participants in the study will be randomly assigned to receive either the standard treatment for TBI or the standard treatment plus FFP. By comparing the two groups, researchers hope to learn more about the benefits and safety of using FFP in these situations.

To be eligible for this trial, participants need to be between 18 and 65 years old and have a moderate to severe TBI, which means their level of consciousness is affected. However, certain individuals may not qualify, including those with a history of serious reactions to plasma treatments or other significant health issues. If someone decides to participate, they can expect to receive either regular care or regular care plus FFP while being closely monitored for safety and effectiveness. This trial is not yet recruiting participants, but it aims to provide valuable insights into improving care for those with traumatic brain injuries.

Gender

ALL

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)