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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-1-0241 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Standard of Care + Normal Saline (0.9% sodium chloride solution) |
|
| Experimental | Experimental | Standard of care treatment + one dose of VPA (in 250 ml 0.9% sodium chloride solution) in the following two doses:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic Acid (VPA) | Drug | VPA (in 250 ml 0.9% sodium chloride solution) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 24 hours post-injury as measured by a CT scan |
| Disability Rating Score (DRS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Alam, MD | Contact | 312-926-4962 | Hasan.Alam@nm.org | |
| Nicole Meredyth, MD | Contact | 312-694-4867 | nicole.meredyth@nm.org |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41420823 | Derived | 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. 2026 May;66 Suppl 1(Suppl 1):S266-S277. doi: 10.1111/trf.70029. Epub 2025 Dec 20. |
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Aggregate data will be shared.
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Randomized, Placebo-Controlled
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| Standard of care treatment + normal saline |
| Other |
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml) |
|
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. |
| Discharge or day 7 and 3 months post-injury |
| 6 months post-injury |
| 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. | 6 months post injury |
| Glasgow Coma Scale (GCS) | Evaluates three behavior responses: eye opening, best verbal and best motor. The following scoring is associated with responses: Eye opening response - Spontaneously 4, To speech 3, To pain 2 and No response 1; Best verbal - Oriented to time/place/person 5, Confused 4, Inappropriate words 3, Incomprehensible sounds 2 and No response 1; and Best motor response - Obeys commands 6, Moves to localized pain 5, Flexion withdrawal from pain 4, Abnormal flexion 3, Abnormal extension 2 and No response 1. The scoring is totaled with higher values associated with better response. Total Score: Best response=15, Comatose client=8 or less, and Totally unresponsive=3. | 24 hours post-injury |
| University of Arizona | Tucson | Arizona | 85719-4824 | United States |
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| University of Southern California | Los Angeles | California | 90089-0701 | United States |
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| University of California, Davis | Sacramento | California | 95817 | United States |
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| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
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| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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