ISRCTN22153967已完成未知
Surgical Trial in Lobar Intracerebral Haemorrhage
ewcastle upon Tyne Hospitals NHS Trust (UK)0 个研究点目标入组 600 人开始时间: 2006年10月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21586127 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23726393 results 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29321340 retrospective methods analysis 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37161757/ (added 10/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Evidence of a spontaneous lobar ICH on Computed Tomography (CT) scan (within 1 cm of the cortical surface)
- •2. Patient within 48 hours of ictus
- •3. The 'clinical uncertainty principle' is used: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible. These include patients with a haematoma volume of between 10 and 100 ml and a best motor score on the Glasgow Coma Score (GCS) of five or six together with some eye opening
排除标准
- •1. Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation
- •2. Intraventricular haemorrhage of any sort
- •3. ICH secondary to tumour or trauma
- •4. Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions
- •5. Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome
- •6. If surgery cannot be performed within 12 hours
研究者
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