Valproic AcId for Traumatic BRAin INjury Trial

NCT ID: NCT07166393

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2030-12-31

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

Standard of care treatment + normal saline

Intervention Type: OTHER

Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)

Experimental

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

Group Type: EXPERIMENTAL

Valproic Acid (VPA)

Intervention Type: DRUG

VPA (in 250 ml 0.9% sodium chloride solution)

Interventions

Valproic Acid (VPA)

VPA (in 250 ml 0.9% sodium chloride solution)

Intervention Type: DRUG

Standard of care treatment + normal saline

Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Hasan Alam

Chair, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

University of Southern California

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

Oregon Health & Science University

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Central Contacts

Hasan Alam, MD

Role: CONTACT

Hasan.Alam@nm.org

312-926-4962

Nicole Meredyth, MD

Role: CONTACT

nicole.meredyth@nm.org

312-694-4867

Facility Contacts

Joel Rodgers

Role: primary

jrodgers@uabmc.edu

205-515-3590

Robin Carlson, PhD

Role: primary

rscarlson@arizona.edu

520-626-2876

Monica Wong

Role: primary

monica.wong@med.usc.edu

323-409-8597

Shari Nichols

Role: primary

slnichols@health.ucdavis.edu

Samanatha Underwood

Role: primary

underwos@ohsu.edu

503-494-5400

Heather White

Role: primary

Heather.white@vumc.org

615-421-2996

Katherine Bosler

Role: primary

katherine.bosler@utsowthwestern.edu

Madison Rundell, BS

Role: primary

mrundell@mcw.edu

Other Identifiers

HT9425-24-1-0241

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00223546

Identifier Type: -

Identifier Source: org_study_id