Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Rebleeding rate before anerysm clipping
研究概览
简要总结
The goal of this clinical trial is to determine the most effective timing for clipping in adults with ruptured intracranial aneurysms. It will also assess the safety of performing the surgery at different times of early period after the aneurysm has ruptured. The main questions it aims to answer are:
- Does ultra-early surgical intervention ( less than 24 hours of rupture) improve survival rates compared to delayed surgery (24 to 72 hours after rupture)?
- What are the complication rates associated with early versus delayed surgical intervention?
Researchers will compare clipping in ultra-early period to surgery in early period to see if timing affects the outcomes for treating ruptured intracranial aneurysms.
Participants will:
- Be randomly assigned to undergo surgical clipping either within 24 hours of rupture or between 24 hours to 72 hours after the rupture.
- Visit the clinic for follow-up assessments at 1 month, 3 months, 6 months, and 12 months post-surgery.
- Keep a diary of their symptoms, neurological function, and any complications they experience post-surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aneurysmal subarachnoid hemorrhage
- •patient eligible for surgical clipping
- •patients with informed consent for inclusion into the study
排除标准
- •patients admitted and treated >72 h after subarachnoid hemorrhage onset
- •patients with severe comorbidities
- •patients with multiple aneurysms
结局指标
主要结局
Rebleeding rate before anerysm clipping
时间窗: baseline, pre-surgery
The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.
次要结局
- Clinical outcome according to the Modified Rankin Scale(Up to 12 months after aneurysm surgery)
- Delayed cerebral ischemia(Up to 3 weeks after aneurysm rupture)
- Rate of occlusion according to modified Raymond-Roy classification(Up to 12 months after aneurysm surgery)
研究者
Revaz Dzhindzhikhadze
Chief of neurosurgical department
Moscow Regional Research and Clinical Institute (MONIKI)