Northwestern University

VIBRANT – Valproic AcId for Traumatic BRAin INjury Trial

This research study is called: “Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients with Moderate to Severe Traumatic Brain Injury (TBI)” or “VIBRANT-Valproic AcId for Traumatic BRAin INjury Trial.” The purpose of the research study is to learn more about an investigational treatment, valproic acid (a drug that was developed and approved to treat patients with seizures), in treating traumatic injuries to the brain. “Investigational” means that valproic acid 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 valproic acid 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. Some early evidence in people suggests that valproic acid could be a good treatment option.

For the study, we will have three groups of patients with moderate to severe TBI: a group receiving usual care, a group receiving usual care plus one low dose treatment of valproic acid, and a group receiving usual care plus one high dose treatment of valproic acid. We will look at the three groups of people and see if any of the groups did better than the others. We will also collect information from health records for the three 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.

Do you have any comments you would like to tell the researchers about this study? We would value your feedback via the link below. Your feedback will remain confidential.

Do you have any comments you would like to tell the researchers about this study?  We would value your feedback via the link below.  Your feedback will remain confidential.