FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
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:
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.
Public Health Relevance:
Traumatic Brain Injury (TBI) affects > 2 million individuals in the US annually with a economic burden of >$80 billion. This study seeks to mitigate the effects of TBI-related hemorrhage through transfusion of fresh frozen plasma (FFP). The FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial will determine the safety and efficacy of plasma transfusion in improving TBI outcomes.