Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 432
- 试验地点
- 9
- 主要终点
- Extended Glasgow Outcome Scale (GOS-E)
研究概览
简要总结
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:
- Standard of care treatment and normal saline
- Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 65 years.
- •Body Mass Index between 18 kg/m2 and 35 kg/m
- •Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
- •Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-
- •Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3) criteria
排除标准
- •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
研究组 & 干预措施
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
干预措施: Valproic Acid (VPA) (Drug)
Control
Standard of Care + Normal Saline (0.9% sodium chloride solution)
干预措施: Standard of care treatment + normal saline (Other)
结局指标
主要结局
Extended Glasgow Outcome Scale (GOS-E)
时间窗: 3 months post-injury
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.
次要结局
- Hemorrhagic progression of the contusion (HPC)(First 24 hours post-injury as measured by a CT scan)
- Disability Rating Score (DRS)(Discharge or day 7 and 3 months post-injury)
研究者
Hasan Alam
Chair, Department of Surgery
Northwestern University