Valproic AcId for Traumatic BRAin INjury Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Valproic Acid (VPA), Standard of care treatment + normal saline.
- Who it may be relevant to
- Registry conditions: Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
Overview
The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI). Patients with moderate to severe TBI will randomly receive either: 1. Standard of care treatment and normal saline 2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
Detailed description
The specific aim is to determine whether giving VPA at either a 50 mg/kg dose or a 100 mg/kg is safe (as measured by adverse events after treatment) in patients with moderate to severe TBI due to brain bruises.
Interventions
- Drug Valproic Acid (VPA)
VPA (in 250 ml 0.9% sodium chloride solution) - Other Standard of care treatment + normal saline
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Primary outcome measures
- Extended Glasgow Outcome Scale (GOS-E) [Time frame: 3 months post-injury]
Secondary outcome measures (2)
- Hemorrhagic progression of the contusion (HPC) [Time frame: First 24 hours post-injury as measured by a CT scan]
- Disability Rating Score (DRS) [Time frame: Discharge or day 7 and 3 months post-injury]
Eligibility criteria
Inclusion criteria
- Male or female between the ages of 18 and 65 years.
- Body Mass Index between 18 kg/m2 and 35 kg/m2.
- Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
- Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria
Exclusion criteria
- Persons with known history of adverse reactions to VPA
- Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
- Persons with a known history of thrombocytopenia.
- Persons with platelet count less than 100,000 per microliter of blood.
- Persons with 2nd or 3rd degree burns of any size and location.
- Female subjects who are pregnant or lactating.
- Persons who are currently incarcerated or are in police custody.
- Persons with inadequate venous access.
- Treatment cannot start within 120 minutes from the onset of injury
- Non-survivable injuries in the estimation of the attending trauma surgeon.
- Interfacility transfers
- The time of injury is unknown
- Patients in hemorrhagic shock with a systolic blood pressure of <90 mmHg on initial evaluation.
- Persons with a known "do not resuscitate" order prior to randomization
- Persons with a research "opt out" bracelet
- Persons who are currently enrolled in another clinical trial.
- Greater than 90 minutes between the onset of injury and arrival to the hospital
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- University of Alabama at Birmingham — Birmingham
- University of Arizona — Tucson
- University of Southern California — Los Angeles
- University of California, Davis — Sacramento
- Oregon Health & Science University — Portland
- Vanderbilt University Medical Center — Nashville
- University of Texas Southwestern — Dallas
- Medical College of Wisconsin — Milwaukee
Publications
- Visa MA, Liggett MR, Lashley S, Bhatti U, Dawood ZA, Anand A, Gill NP, Scholtens DM, Wang B, Alam HB. Valproic acid for treatment of traumatic brain injury: Study protocol for the VIBRANT prospective randomized trial. Transfusion. 2026 May;66 Suppl 1(Suppl 1):S266-S277. doi: 10.1111/trf.70029. Epub 2025 Dec 20. PMID 41420823
Identifiers
NCT: NCT07166393 · STU00223546 · HT9425-24-1-0241