Valproic AcId for Traumatic BRAin INjury Trial
VIBRANT
Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
2 other identifiers
interventional
432
1 country
8
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
September 22, 2025
September 1, 2025
3.8 years
September 3, 2025
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extended Glasgow Outcome Scale (GOS-E)
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
3 months post-injury
Secondary Outcomes (2)
Hemorrhagic progression of the contusion (HPC)
First 24 hours post-injury as measured by a CT scan
Disability Rating Score (DRS)
Discharge or day 7 and 3 months post-injury
Other Outcomes (3)
Disability Rating Score (DRS)
6 months post-injury
Extended Glasgow Outcome Scale (GOS-E)
6 months post injury
Glasgow Coma Scale (GCS)
24 hours post-injury
Study Arms (2)
Control
PLACEBO COMPARATORStandard of Care + Normal Saline (0.9% sodium chloride solution)
Experimental
EXPERIMENTALStandard of care treatment + one dose of VPA (in 250 ml 0.9% sodium chloride solution) in the following two doses: * Lower dose VPA: 50 mg/kg * Higher dose VPA: 100 mg/kg
Interventions
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- United States Department of Defensecollaborator
Study Sites (8)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85719-4824, United States
University of Southern California
Los Angeles, California, 90089-0701, United States
University of California, Davis
Sacramento, California, 95817, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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. 2025 Dec 20. doi: 10.1111/trf.70029. Online ahead of print.
PMID: 41420823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hasan Alam, MD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Surgery
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 10, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Aggregate data will be shared.