Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 860
- 主要终点
- Glasgow Outcome Scale Extended (GOSE) at 6 months
研究概览
简要总结
Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the investigators have no medication to treat the bad effects of head trauma. Part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.
详细描述
Dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its dextro-configuration is compatible with activation of cannabinoid receptors in the brain. It combines the ability to block NMDA receptors and neuroinflammatory cascades in the same molecule. Dexanabinol scavenges free radicals, protects neurons from toxicity of free radical generators and inhibits lipopolysaccharide-induced production of prostaglandin E2, NO and TNF-a by macrophages in culture.
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
- Double
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
- •Traumatic head injury within the last 6 hours
- •Glasgow Coma Motor score of 2 to 5; severity requires intracranial pressure (ICP) monitoring
- •Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable
- •An informed consent
排除标准
- •Penetrating head injury
- •Spinal cord injury
- •Coma due to pure epidural hematoma with initial Glasgow Coma Scale (GCS) of => 12
- •Previous major cerebral damage
- •Concomitant severe conditions
结局指标
主要结局
Glasgow Outcome Scale Extended (GOSE) at 6 months
次要结局
- GOSE at 3 months
- Mortality rates at 10 days and 6 months
- Intracerebral pressure during first 72 hours of trauma
- Neuroworsening at 10 days
- Quality of life