Valproic AcId for Traumatic BRAin INjury Trial (VIBRANT)

Northwestern University

Status and phase: Begins enrollment in 2 months; Phase 3; Phase 2

Conditions: Moderate Traumatic Brain Injury (TBI); Severe Traumatic Brain Injury

Treatments: Drug: Valproic Acid (VPA); Other: Standard of care treatment + normal saline

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07166393

HT9425-24-1-0241 (Other Grant/Funding Number)

STU00223546

Details and patient eligibility

About

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

Full 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.

Enrollment: 432 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female between the ages of 18 and 65 years.
2. Body Mass Index between 18 kg/m2 and 35 kg/m2.
3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria

Exclusion criteria

1. Persons with known history of adverse reactions to VPA
2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
3. Persons with a known history of thrombocytopenia.
4. Persons with platelet count less than 100,000 per microliter of blood.
5. Persons with 2nd or 3rd degree burns of any size and location.
6. Female subjects who are pregnant or lactating.
7. Persons who are currently incarcerated or are in police custody.
8. Persons with inadequate venous access.
9. Treatment cannot start within 120 minutes from the onset of injury
10. Non-survivable injuries in the estimation of the attending trauma surgeon.
11. Interfacility transfers
12. The time of injury is unknown
13. Patients in hemorrhagic shock with a systolic blood pressure of <90 mmHg on initial evaluation.
14. Persons with a known "do not resuscitate" order prior to randomization
15. Persons with a research "opt out" bracelet
16. Persons who are currently enrolled in another clinical trial.
17. Greater than 90 minutes between the onset of injury and arrival to the hospital

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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432 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Standard of Care + Normal Saline (0.9% sodium chloride solution)

Treatment:

Other: Standard of care treatment + normal saline

Experimental

Experimental group

Description:

Standard 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

Treatment:

Drug: Valproic Acid (VPA)