Phase 3 Study (Multi-center, Randomized Controlled Clinical Trial) of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Extended Glasgow Outcome Scale
研究概览
简要总结
The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center trial to answer the question: "Does intravenous magnesium sulfate improve clinical outcome after aneurysmal subarachnoid hemorrhage?"
详细描述
Vasospasm worsen outcome in patients with aneurysmal subarachnoid hemorrhage (ASAH).
Magnesium is known to dilate cerebral arteries and to block N-methyl-D-aspartate receptors in the injured neurons.
Intravenous magnesium may prevent vasospasm after subarachnoid hemorrhage and may protect neurons against damage during established vasospasm.
The IMASH trial is a randomized, placebo-controlled, double-blinded, multi-center trial to evaluate the effect that intravenous magnesium sulfate infusion on the clinical outcome of patients with aneurysmal subarachnoid haemorrhage.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASAH (as indicated by CT scan or lumbar puncture and an intracranial aneurysm confirmed by computer tomographic or conventional angiography)
- •Within 48 hrs of ictus (hemorrhage event)
排除标准
- •Pregnancy
- •Major renal, hepatic or pulmonary disease
- •Major cardiac disease or recent myocardial infarct (< 6 months)
- •Age less than 18 years
- •Moribund condition on admission (defined as a patient that is in such a poor clinical condition that further active neurosurgical management would not be anticipated)
研究组 & 干预措施
M
Intravenous magnesium sulfate infusion for 14 days.
干预措施: Intravenous magnesium sulfate infusion (Drug)
结局指标
主要结局
Extended Glasgow Outcome Scale
时间窗: At six months
次要结局
- Incidence of clinical vasospasm(Within first 14 days)
- Barthel Index(At six months)
- Modified Rankin Score(At six months)
- Modified National Institute of Health Stroke Score(At six months)
- Other major complications requiring intensive care unit admission(During first 14 days)