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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
432
VPA (in 250 ml 0.9% sodium chloride solution)
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
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
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.
Time frame: 3 months post-injury
Hemorrhagic progression of the contusion (HPC)
We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan.
Time frame: First 24 hours post-injury as measured by a CT scan
Disability Rating Score (DRS)
This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.
Time frame: Discharge or day 7 and 3 months post-injury
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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