Summary

Eligibility
for people ages 18-65 (full criteria)
Dates
study started
completion around

Description

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, 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)

Details

The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 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.

Keywords

Moderate to Severe Traumatic Brain Injury, TBI, Traumatic Brain Injury, Brain Injuries, Traumatic Brain Injuries, Wounds and Injuries, Fresh Frozen Plasma (FFP)

Eligibility

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT06062888
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 357 study participants
Last Updated