Surgical Trial in Lobar Intracerebral Haemorrhage
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale/ Modified Rankin Scale
研究概览
简要总结
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.
This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.
详细描述
STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
- •Patient within 48 hours of ictus
- •Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
- •Volume of haematoma between 10 and 100ml [Calculated using (a x b x c)/2 method]
排除标准
- •Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- •Intraventricular haemorrhage of any sort
- •ICH secondary to tumour or trauma.
- •Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
- •Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
- •If surgery cannot be performed within 12 hours.
- •If the haematological effects of any previous anticoagulants are not completely reversed.
结局指标
主要结局
Glasgow Outcome Scale/ Modified Rankin Scale
时间窗: six months
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale
次要结局
未报告次要终点