Valproic AcId for Traumatic BRAin INjury Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Valproic Acid (VPA), Standard of care treatment + normal saline.
- Кому может быть актуально
- Состояния в реестре: Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
Обзор
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
Подробное описание
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.
Вмешательства
- Препарат Valproic Acid (VPA)
VPA (in 250 ml 0.9% sodium chloride solution) - Другое Standard of care treatment + normal saline
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Первичные конечные точки
- Extended Glasgow Outcome Scale (GOS-E) [Срок оценки: 3 months post-injury]
Вторичные конечные точки (2)
- Hemorrhagic progression of the contusion (HPC) [Срок оценки: First 24 hours post-injury as measured by a CT scan]
- Disability Rating Score (DRS) [Срок оценки: Discharge or day 7 and 3 months post-injury]
Критерии участия
Критерии включения
- Male or female between the ages of 18 and 65 years.
- Body Mass Index between 18 kg/m2 and 35 kg/m2.
- Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
- Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria
Критерии исключения
- Persons with known history of adverse reactions to VPA
- Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
- Persons with a known history of thrombocytopenia.
- Persons with platelet count less than 100,000 per microliter of blood.
- Persons with 2nd or 3rd degree burns of any size and location.
- Female subjects who are pregnant or lactating.
- Persons who are currently incarcerated or are in police custody.
- Persons with inadequate venous access.
- Treatment cannot start within 120 minutes from the onset of injury
- Non-survivable injuries in the estimation of the attending trauma surgeon.
- Interfacility transfers
- The time of injury is unknown
- Patients in hemorrhagic shock with a systolic blood pressure of <90 mmHg on initial evaluation.
- Persons with a known "do not resuscitate" order prior to randomization
- Persons with a research "opt out" bracelet
- Persons who are currently enrolled in another clinical trial.
- Greater than 90 minutes between the onset of injury and arrival to the hospital
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 8 центров
- University of Alabama at Birmingham — Birmingham
- University of Arizona — Tucson
- University of Southern California — Los Angeles
- University of California, Davis — Sacramento
- Oregon Health & Science University — Portland
- Vanderbilt University Medical Center — Nashville
- University of Texas Southwestern — Dallas
- Medical College of Wisconsin — Milwaukee
Публикации
- 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. PMID 41420823
Идентификаторы
NCT: NCT07166393 · STU00223546 · HT9425-24-1-0241