EARLYdrain - Prospective Outcome Study of Early Lumbar Drainage in Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD)
研究概览
简要总结
The intention of the study is to investigate whether drainage of cerebral spinal fluid via a lumbar route ("Tuohy-drain") will improve outcome after intracranial aneurysmal subarachnoid hemorrhage (SAH).
详细描述
- Introduction
Patients suffering from aneurysmal subarachnoid hemorrhage (SAH) are predominantly threatened by two distinct medical problems. Firstly, they may experience a second - and often more severe - hemorrhage, and secondly, they may suffer a constringence reaction of the vessels supplying the brain with blood, called vasospasm.
The first problem is resolved by rapid cerebrovascular imaging and subsequent treatment of the ruptured aneurysm, thus preventing recurrent hemorrhage. Aneurysm treatment may be performed either via craniotomy and surgical clipping of the aneurysm or with endovascular techniques by occluding the aneurysm with small platinum coils.
The vasospasm - the second problem - is more difficult to handle. A hypothesis is that the development of vasospasm is related to the amount of blood in the basal cisterns. Therefore, a possible strategy tries to remove this blood as much as possible. Excess removal of cerebral spinal fluid (CSF) via an external ventricular drain fails in preventing vasospasm and may lead to a higher incidence of posthemorrhagic shunt dependency. Reason is that after aneurysmal SAH, the blood is packed more densely in the basal cisterns and therefore only CSF, being more lightweight, is drained from the ventricles. As an alternative approach, application of a lumbar drain is proposed to address clotting of the blood in the basal cisterns. Three retrospective studies in patients after aneurysmal SAH, the newest being available only as abstract, were able to establish the safety of this approach (Klimo et al, Kwon et al, Tizi et al (abstract DGNC 2009)). One of the fully published studies addressed vasospasm prophylaxis after surgical clipping, while the other was performed in patients after endovascular coiling. All studies led to a markedly diminished incidence of angiographic vasospasm. Therefore, a prospective study addressing the efficacy of this novel therapeutic approach is warranted.
The focus of the EARLYDRAIN study is to examine the efficacy of application of lumbar drainage in patients with acute subarachnoidal hemorrhage from a cerebral aneurysm. Hypothesis is that early application of lumbar drainage after aneurysmal SAH leads to a diminished incidence of cerebral vasospasm, as assessed by digital subtraction angiography, and an improved outcome, measured by the modified Rankin score, at six months. 2. Study outline
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older
- •First aneurysmal SAH
- •Pre-morbid modified Rankin Scale score 0 or 1
- •Aneurysm treatment performed in the first 48 hours after the initial hemorrhage.
- •Informed consent by the patient or his/her legal representative. In case neither the patient is capable of giving informed consent nor a legal representative is available, informed consent can be given by an independent physician neither involved in the patient´s treatment nor the trial (for specification see below)
排除标准
- •Subarachnoid hemorrhage of other than aneurysmal origin
- •No hemorrhage visible on initial CCT scan (Fisher Grade I)
- •Pregnancy
- •Concurrent participation in another interventional trial (participation in an observational trial is allowed)
- •Life expectancy less than 1 year for other reasons than the actual SAH
- •Other concomitant severe disease that would confound with treatment
- •Other clear contraindication for treatment
结局指标
主要结局
Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD)
时间窗: 6 months after SAH
Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 2 versus 3 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit. Alternatively, a telephone questionnaire is suitable for outcome assessment of the modified Rankin Scale (13). Outcome assessment is planned to be done on the whole dataset as well as in preplanned stratified subsets (i.e. for example clinical SAH grade according to the Hunt\&Hess scale 1-2 vs. 3-5 (14), CT grading according to Fisher I-III vs. IV (15)).
次要结局
- Expression of clinical delayed neurological deficit(day 1-14 after SAH)
- mortality(6 months after SAH)
- Angiographically determined vasospasm(once between day 7 to 9 after SAH)
- Modified Rankin scale (mRS) score as continuous variable(6 months after SAH)
- Vasospastic infarction(last CT-scan during hospital stay, an expected average of 4 weeks)
- Transcranial duplex ultrasound measured flow velocity in both middle cerebral arteries(daily during hospital stay of the patient)
- Early mortality(Time span of initial hospital treatment after SAH, an expected average of 4 weeks)
- Presence of CSF infection(First 14 days after SAH)
- Rate of CSF shunt insertion in the first six months(First 6 months after SAH)
研究者
Dr. Stefan Wolf
Stefan Wolf, MD
Charite University, Berlin, Germany