Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT07166393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valproic AcId for Traumatic BRAin INjury Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Placebo-Controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 432}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disability Rating Score (DRS)', 'timeFrame': '6 months post-injury', 'description': '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.'}, {'measure': 'Extended Glasgow Outcome Scale (GOS-E)', 'timeFrame': '6 months post injury', 'description': '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.'}, {'measure': 'Glasgow Coma Scale (GCS)', 'timeFrame': '24 hours post-injury', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Extended Glasgow Outcome Scale (GOS-E)', 'timeFrame': '3 months post-injury', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hemorrhagic progression of the contusion (HPC)', 'timeFrame': 'First 24 hours post-injury as measured by a CT scan', 'description': '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.'}, {'measure': 'Disability Rating Score (DRS)', 'timeFrame': 'Discharge or day 7 and 3 months post-injury', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TBI, traumatic brain injury, VPA, valproic acid'], 'conditions': ['Moderate Traumatic Brain Injury (TBI)', 'Severe Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '41420823', 'type': 'DERIVED', 'citation': '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. 2025 Dec 20. doi: 10.1111/trf.70029. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPatients with moderate to severe TBI will randomly receive either:\n\n1. Standard of care treatment and normal saline\n2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 65 years.\n2. Body Mass Index between 18 kg/m2 and 35 kg/m2.\n3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.\n4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.\n5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria\n\nExclusion Criteria:\n\n1. Persons with known history of adverse reactions to VPA\n2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.\n3. Persons with a known history of thrombocytopenia.\n4. Persons with platelet count less than 100,000 per microliter of blood.\n5. Persons with 2nd or 3rd degree burns of any size and location.\n6. Female subjects who are pregnant or lactating.\n7. Persons who are currently incarcerated or are in police custody.\n8. Persons with inadequate venous access.\n9. Treatment cannot start within 120 minutes from the onset of injury\n10. Non-survivable injuries in the estimation of the attending trauma surgeon.\n11. Interfacility transfers\n12. The time of injury is unknown\n13. Patients in hemorrhagic shock with a systolic blood pressure of \\<90 mmHg on initial evaluation.\n14. Persons with a known "do not resuscitate" order prior to randomization\n15. Persons with a research "opt out" bracelet\n16. Persons who are currently enrolled in another clinical trial.\n17. Greater than 90 minutes between the onset of injury and arrival to the hospital'}, 'identificationModule': {'nctId': 'NCT07166393', 'acronym': 'VIBRANT', 'briefTitle': 'Valproic AcId for Traumatic BRAin INjury Trial', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'STU00223546'}, 'secondaryIdInfos': [{'id': 'HT9425-24-1-0241', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard of Care + Normal Saline (0.9% sodium chloride solution)', 'interventionNames': ['Other: Standard of care treatment + normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Standard of care treatment + one dose of VPA (in 250 ml 0.9% sodium chloride solution) in the following two doses:\n\n* Lower dose VPA: 50 mg/kg\n* Higher dose VPA: 100 mg/kg', 'interventionNames': ['Drug: Valproic Acid (VPA)']}], 'interventions': [{'name': 'Valproic Acid (VPA)', 'type': 'DRUG', 'description': 'VPA (in 250 ml 0.9% sodium chloride solution)', 'armGroupLabels': ['Experimental']}, {'name': 'Standard of care treatment + normal saline', 'type': 'OTHER', 'description': 'Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Joel Rodgers', 'role': 'CONTACT', 'email': 'jrodgers@uabmc.edu', 'phone': '205-515-3590'}, {'name': 'Jan Jansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85719-4824', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'contacts': [{'name': 'Robin Carlson, PhD', 'role': 'CONTACT', 'email': 'rscarlson@arizona.edu', 'phone': '520-626-2876'}, {'name': 'Joseph Bellal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90089-0701', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Monica Wong', 'role': 'CONTACT', 'email': 'monica.wong@med.usc.edu', 'phone': '323-409-8597'}, {'name': 'Matthew Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kenji Inaba, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Shari Nichols', 'role': 'CONTACT', 'email': 'slnichols@health.ucdavis.edu'}, {'name': 'Rachael Callcut, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rachel Russo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'contacts': [{'name': 'Samanatha Underwood', 'role': 'CONTACT', 'email': 'underwos@ohsu.edu', 'phone': '503-494-5400'}, {'name': 'Mitchell Sally, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Heather White', 'role': 'CONTACT', 'email': 'Heather.white@vumc.org', 'phone': '615-421-2996'}, {'name': 'Amelia Maiga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mayur Patel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Katherine Bosler', 'role': 'CONTACT', 'email': 'katherine.bosler@utsowthwestern.edu'}, {'name': 'Linda Dultz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Madison Rundell, BS', 'role': 'CONTACT', 'email': 'mrundell@mcw.edu'}, {'name': 'Marc de Moya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Hasan Alam, MD', 'role': 'CONTACT', 'email': 'Hasan.Alam@nm.org', 'phone': '312-926-4962'}, {'name': 'Nicole Meredyth, MD', 'role': 'CONTACT', 'email': 'nicole.meredyth@nm.org', 'phone': '312-694-4867'}], 'overallOfficials': [{'name': 'Hasan Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Surgery', 'investigatorFullName': 'Hasan Alam', 'investigatorAffiliation': 'Northwestern University'}}}}