Status:
NOT_YET_RECRUITING
Valproic AcId for Traumatic BRAin INjury Trial
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Moderate Traumatic Brain Injury (TBI)
Severe Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
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 brai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT07166393
Start Date
May 1 2026
End Date
December 1 2030
Last Update
September 22 2025
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arizona
Tucson, Arizona, United States, 85719-4824
3
University of Southern California
Los Angeles, California, United States, 90089-0701
4
University of California, Davis
Sacramento, California, United States, 95817