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This research study is called: “Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients with Moderate to Severe Traumatic Brain Injury (TBI)” or “FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial.” The purpose of the research study is to learn more about an investigational treatment, plasma (the colorless fluid part of blood), in treating traumatic injuries to the brain. “Investigational” means that the plasma as a treatment for traumatic brain injury is under investigation and is not approved for this use in the United States by the Food and Drug Administration (FDA). The goal of the study is to see how fresh frozen plasma (FFP) given one time for moderate to severe TBI shortly after the injury will protect the brain. The study will also look at injury recovery.
A traumatic brain injury is when someone's brain gets hurt because of a sudden and strong impact to their head from accidents like falling, getting hit on the head, or being in a car crash. Traumatic brain injuries cause a range of problems, like headaches, dizziness, trouble thinking, or even problems with moving and talking. Fresh Frozen Plasma (FFP) is a special part of blood used to help people with severe injuries, particularly when they are bleeding heavily. Some early evidence in people suggests that it could be a good treatment option.
For the study, we will have two groups of patients with moderate to severe TBI: a group receiving usual care and a group receiving usual care plus one treatment with Fresh Frozen Plasma. We will look at both groups of people and see if one group did better than the other. We will also collect information from health records for both groups as part of the study.
People who are included in studies looking at emergency treatments like this one are very sick and cannot give permission beforehand. However, we must tell the person as soon as we can that they are in the study and give them a chance to decide if they want to keep participating.
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