NL-OMON50259招募中不适用
Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral hemorrhage: a randomized controlled trial - SWITCH: decompressive surgery for spontaneous intracerebral hemorrhage
Inselspital, universitätsspital Bern0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age: >=18 to <=75 years
- •- Deep ICH (basal ganglia or thalamus) that may extend into cerebral lobes,
- •ventricles or subarachnoid space
- •- Acute stroke syndrome due to a spontaneous ICH
- •- NIHSS score of >=10 and <=30
- •- Glasgow coma scale (GCS) >7 and <14
- •- Randomization within 66 hours after ictus
- •- Surgical treatment not later than 6 hours after randomization
- •- Volume of hematoma >=30 ml and <=100 ml
排除标准
- •- ICH due to known or suspected structural abnormality in the brain (e.g.,
- •intracranial aneurysm, brain arteriovenous malformation, brain tumor) or brain
- •trauma, or previous stroke thrombolysis
- •- Cerebellar or brainstem hemorrhage
- •- Exclusive lobar hemorrhage
- •- Moribund patients (GCS 3-7)
- •- Patient has a signed do-not-treat statement
- •- Known advanced dementia or significant pre-stroke disability
- •- Concomitant medical illness that would interfere with outcome assessment and
- •- Pregnancy
- •- Prior major brain surgery within <6 month or prior DC
- •- Foreseeable difficulties in follow-up due to geographic reasons
- •- Known definite contraindication for a surgical procedure
- •- A very high likelihood that the patient will die within the next 24 hours on
- •the basis of clinical and/or radiological criteria
- •- Previous participation in this trial or in another ongoing investigational
- •- Prior symptomatic ICH
- •- ICH secondary to thrombolysis
- •- Bilateral areactive pupils
研究者
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