Effects of Aspirin on postoperative cerebral vasospasm and delayed cerebral ischemia in aneurysmal subarachnoid haemorrhage A prospective, randomized, single-blinded pilot trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Aspirin decreases the incidence of postoperative cerebral vasospasm and delayed cerebral ischaemia in patients with aneurysmal subarachnoid haemorrhage
研究概览
简要总结
This study is a randomized, controlled, single centre trial, comparing the effects of Aspirin 75mg once daily in 92 patients with aneurysmal subarachnoid hemorrhage who have undergone clipping of aneurysm on postoperative cerebral vasospasm and delayed cerebral ischemia. The duration of the study is for 18 months. The primary outcome is comparison between the incidence of cerebral vasospasm and delayed cerebral ischemia in the treatment group (Aspirin + Nimodipine) versus control group (Nimodipine) at 3 months. The secondary outcome is to compare the inflammatory markers (TLC, ESR, CRP) in both groups and functional outcome by mRS of patients in both groups at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Patients visiting the AIIMS Jodhpur emergency or OPD or admitted under the Department of Neurosurgery in the study duration
- •Age above 18 years, and
- •Patients with SAH caused by ruptured intracranial aneurysm.
排除标准
- •Exclusion criteria:
- •Patients with non aneurysmal SAH
- •Patients with known allergy to aspirin
- •Pregnancy
- •Patients with known bleeding diathesis.
结局指标
主要结局
Aspirin decreases the incidence of postoperative cerebral vasospasm and delayed cerebral ischaemia in patients with aneurysmal subarachnoid haemorrhage
时间窗: Outcomes will be assessed and compared at 3 months
次要结局
- improved quality of life and decreased morbidity of patients(aspirin by preventing cerebral vasospasm and delayed cerebral ischaemia will decrease the morbidity and improve the quality of life after the surgery)
研究者
Advait Pakhmode
AIIMS jodhpur