Traumatic brain injury (TBI) affects more than 2 million people in the U.S. each year, resulting in nearly 70,000 deaths. Researchers at Vanderbilt University Medical Center are asking for community input on whether they should participate in a study that will use one dose of fresh frozen plasma (FFP) to treat patients with traumatic brain injury starting about one hour after they arrive at the hospital.
The goal of the research is to determine if this treatment reduces the amount their brain lesion (brain bruise) grows and leads to better long-term brain function.
Currently, there are no treatment options available that can specifically help the injured brain and lessen the extent of brain damage. Developing a treatment strategy can have a significant impact on the care and treatment of these trauma patients.
The FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial will compare this treatment strategy in addition to all standard care, to standard of care treatment alone, in injured patients. Studies have shown that giving FFP to TBI patients improves outcomes in patients with massive bleeding, leads to smaller brain lesions and less brain swelling, and leads to better long-term brain function.
Patients in this study will have suffered a serious and potentially life-threatening injury, requiring immediate lifesaving interventions. These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time.
Most patients will be unconscious, unable to speak or hear, and too sick to consent to immediate treatment, or participation in the study. If the community feedback is positive and an institutional review board approves the study, then VUMC will participate in this trial.
Community members who do not want to participate can request a bracelet indicating this. If feasible, doctors will consent patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet.
The FIT-BRAIN Trial will be conducted at eight leading trauma centers in the U.S. and will include about 357 patients. The trial began in early 2024, will last until around 2027 and is funded by the U.S. Department of Defense.
The study team members are asking for feedback from the Nashville area community about this study, to help determine whether the community wants this area to participate in this study. Please consider visiting the website below to learn more about this study and to provide your feedback to the local physicians regarding emergency research. You can do this via phone call, email, or by completing a brief anonymous survey.
The link to the local VUMC website is www.uab.edu/medicine/cis/fit-brain-trial-at-vanderbilt. For additional information, contact 888-244-8700 or fit-brain_trial@northwestern.edu.
