Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Rankin scale (mRS)
研究概览
简要总结
Decompressive craniectomy has been reported for the treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will improve clinical outcomes of poor-grade aSAH patients.
详细描述
Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and permanent disability rates. Decompressive craniectomy, which is beneficial in patients with malignant middle cerebral artery infarction, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain due to surgery. Early therapy with either surgical clipping or neuroradiologic intervention with endovascular coiling is the primary treatment for aSAH. But whether decompressive craniectomy should be employed during the clipping surgery or immediately after coil embolization still have considerable controversy. 80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with analysis and reporting taking 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18yrs and age<60yrs
- •It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
- •Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- •Presentation to our institution in World Federation of Neurological Societies (WFNS) Grade III to V neurological condition with Lateral hematoma
- •Duration from onset to admission is within 48 hours
排除标准
- •Traumatic subarachnoid hemorrhage
- •Patients with cerebral herniation or highly possible to occur before surgery
- •Neurosurgery contraindicated
- •Patients with obvious evidence of acute hydrocephalus on admission
- •Intracranial aneurysm combined with cerebral arteriovenous malformation
- •Patients with obvious evidence of irreparable brainstem or thalamic injury
- •Duration from onset to admission is more than 48 hours
- •Disturbance of communication or poor compliance to blood collection, imageological examination and follow-up
结局指标
主要结局
Modified Rankin scale (mRS)
时间窗: 180 days post SAH
By phone call following-up by senior neurosurgeons
次要结局
- Modified Rankin scale (mRS)(30 days and 90 days post SAH)
- Glosgow Coma Score (GCS)(24 hours postoperation)
- Incidence of delayed cerebral ischemia(30 days post SAH)
- Incidence of herniation(30 days post SAH)
- Incidence of cerebral vasospasm(30 days post SAH)
- Incidence of rebleeding(30 days post SAH)
- Death(30 days post SAH)