Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical evidence and TCD measured MFV indicative of vasospasm
研究概览
简要总结
A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.
详细描述
Study Design and Location:
Investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both genders
- •age over 18 years old
- •diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission.
排除标准
- •subarachnoid hemorrhage due to non-aneurysmal causes
- •cerebral stroke of any type during past month
- •decompensated heart failure, renal failure or hepatic failure
- •difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.
研究组 & 干预措施
Magnesium arm
patients randomized to magnesium therapy at a fixed daily dose of 64 mmol reconstituted in 0.9% saline via continuous intravenous infusion for 14 days after hemorrhage onset, or until discharge or death if it occurred.
干预措施: Magnesium sulfate (Drug)
Placebo arm
patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol.
干预措施: normal saline (Drug)
结局指标
主要结局
Clinical evidence and TCD measured MFV indicative of vasospasm
时间窗: 14 days after onset
Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.
次要结局
- Poor MRS functional score(3 months after the onset)
研究者
Ahmed Mohammed Ateia
Neurology Specialist, MTH; Associate member, Harvard Medical School.
General Committee of Teaching Hospitals and Institutes, Egypt