Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical signs of delayed cerebral ischemia
研究概览
简要总结
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage.
详细描述
Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.
We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (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
- 否
入选标准
- •spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
- •CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
- •the drainage can start prior to the treatment of the ruptured aneurysm
- •informed consent is signed by the patient or his representative
排除标准
- •spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
- •traumatic SAH
- •symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
- •the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
- •the presence of a mass lesion with significant cerebral midline shift
- •all patients whose neurological condition is too poor to allow clinical recognition of signs and symptoms of cerebral vasospasm. This includes all patients with a Hunt and Hess Grade V who failed to improve after initial resuscitation
- •no informed consent
- •mycotic aneurysms
结局指标
主要结局
Clinical signs of delayed cerebral ischemia
时间窗: Patients will be followed for the duration of admission, an expected average of 3 weeks
DCI was diagnosed when all of the following criteria were met: (1) the onset of new neurological deficits such as confusion, disorientation, drowsiness, or focal deficit during post-hemorrhage days (4 to 14); (2) negative findings on CT obtained to rule out other causes of neurological deterioration such as hemorrhage, cerebral edema, or hydrocephalus. (3) No other identifiable cause of neurological deterioration such as hyponatriemia, hypoxia, drug toxicity, infection, or seizures.
次要结局
- dichotomized Glasgow outcome score (GOS)(at discharge, an expected average of 3 weeks after initial bleeding)
- new ischemic lesions on cerebral CT scan(at 3 months after initial bleeding)
- length of stay in intensive care unit(Patients will be followed from initial admission until discharge, an expected average of 3 weeks)
- rebleeding rate of unsecured aneurysms and complications of external lumbar drainage(Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days)
- dichotomized Glasgow outcome score (GOS(at 3 months after initial bleeding)
- clinical signs of delayed cerebral ischemia(At 3 months after initial bleeding)