Lumbar Drainage of Cerebrospinal Fluid in Aneurysmal Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Incidence of delayed ischaemic neurological deficit
研究概览
简要总结
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). Despite modern medicine, the death and disability rate remains high both from the initial bleed and from the associated complications such as vasospasm. This is characterised by neurological impairment seen following the bleed. Despite modern treatment this is still associated with a poor outcome. This has significant implications due to the long term intensive neuro-rehabilitation these patients will require.
A recent study has shown that placing a small drain in the lower back following a subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better outcome. This trial was not optimally performed and so a trial is needed to look at this in more detail. The investigators have set up such a trial in our neurosurgical unit. If the investigators confirm that there is an improvement in patient outcome, it will change our practice in the future.
详细描述
All patients who present to our department with proven aneurysmal SAH and fit the inclusion criteria (see below) will be approached for inclusion into the trial. Written informed consent will be sought prior to recruitment into the study. Written assent from the patient's relatives will be sought in those cases where neurological impairment prevents written informed consent being obtained from the patient. The patient will subsequently be randomised into the control arm or the study arm of the trial. The control arm consists of normal therapeutic intervention, including external ventricular drainage if required for hydrocephalus. Those randomised to the therapeutic arm will have a lumbar drain inserted and set to drain CSF at 5 ml/hour. This will continue until CSF is no longer blood stained or until day 10 following insertion.
Primary outcome measures:
- Incidence of delayed ischaemic neurological deficit. This is defined as new neurological deficit and/or impairment of consciousness without other identifiable cause at least three days post haemorrhage.
New impairment of consciousness is defined as a drop in the Glasgow Coma Score of 1 motor point or 2 verbal/eye opening points.
Secondary outcome measures:
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 haemorrhage.
- •Recruitment prior to day three post-haemorrhage.
- •Written informed consent or relative assent given.
- •WFNS grade 1-
- •Fisher grade 2, 3 and 4 (without space occupying haematoma) on initial CT scan.
- •No intraventricular haemorrhage, space occupying haematoma or other contra-indication to lumbar puncture.
排除标准
- •Non-aneurysmal subarachnoid haemorrhage.
- •Delayed presentation / recruitment (after day three post-haemorrhage)
- •Written informed consent or relative assent denied or unobtainable.
- •WFNS grade 4 or
- •Fisher grade 1 on initial CT scan.
- •Intraventricular haematoma obstructing ventricular outflow.
- •Intracranial haematoma with mass effect.
- •Bleeding diathesis.
结局指标
主要结局
Incidence of delayed ischaemic neurological deficit
时间窗: Within 21 days of haemorrhagic ictus
次要结局
- Incidence of cerebrospinal fluid infection secondary to lumbar drainage(Within 8 weeks of removal of lumbar drain)
- Modified Rankin Score(10 days and 6 months following haemorrhagic ictus)
- Incidence of cerebrospinal fluid shunting(Within 12 months of haemorrhagic ictus)
- Incidence of completed infarct secondary to delayed ischaemic neurological deficit(Within 21 days of ictus)