Lumbar Drainage of Intraventricular Hemorrhage the DRAIN IVH Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 4
- 主要终点
- Rate of mRS
研究概览
简要总结
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.
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
- •ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus
- •Age ≥ 18 y
- •Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well
排除标准
- •Premorbid mRS score > 2
- •Pregnancy
- •Life expectancy <6 months
- •Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures.
- •Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
- •Other clear contraindication for treatment with a lumbar drain
结局指标
主要结局
Rate of mRS
时间窗: 180 days (+/- 14 days)
The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies.
次要结局
- Amount of CSF drained by external ventricular drain(up to 14 days (duration of hospital stay))
- Need for VP shunt(at 180 days)
- Bacterial Ventriculitis/Meningitis leading to antibiotic treatment(up to 14 days (duration of hospital stay))
- Amount of CSF drained by lumbar drain(up to 14 days (duration of hospital stay))
- Mortality(up to 14 days (duration of hospital stay) and 6 month)
- Clearance of intraventricular blood (via neuroimaging with CT or MRI)(up to 14 days (duration of hospital stay))
研究者
Dr. Silvia Schönenberger, MD
Prof. Dr. Silvia Schönenberger
University Hospital Heidelberg