ISRCTN21702227已完成不适用

Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2: a prospective randomised open controlled multicentre comparative trial

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)0 个研究点目标入组 160 人开始时间: 2009年2月5日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Aged 61 years or older, either sex
•2. Clinical signs and symptoms of an unilateral middle cerebral artery (MCA) infarction
•3. National Institutes of Health Stroke Scale (NIHSS) greater than 15 (infarcts of the non-dominant hemisphere) or greater than 20 (infarcts of the dominant hemisphere)
•4. Level of consciousness (LoC) at inclusion greater than 0 (LoC greater than or equal to 1) on item 1a of the NIHSS
•5. Symptom onset greater than 12 and less than 48 hours before operation or admission to the Intensive Care Unit (ICU)
•6. Neuroradiological findings: unilateral ischaemic infarction of the MCA territory, involving the complete or subtotal territory, and at least partially including the basal ganglia. An additional involvement of the anterior cerebral artery (ACA) or posterior cerebral artery (PCA) territories is optional. These criteria may be evident either in initial neuroimaging or in any follow-up:
•6.1. Magnetic resonance imaging (MRI) or non-contrast computed tomography (CT): diffusion lesion involving the complete or subtotal unilateral MCA territory, at least partially involving the basal ganglia
•6.2. Evidence of space-occupying brain oedema (midline shift, compression of lateral ventricle or third ventricle)
•7. Possibility to start treatment within 6 hours after randomisation
•8. Informed consent by the patient or his/her legal representative

•1. Pre-morbid modified Rankin Scale (mRS)
•2. Pre-morbid mRS score less than or equal to 2 or Barthel-Index less than 95
•3. Coincidental or timely associated other brain damage (i.e. trauma and others)
•4. Absence of pupil reflexes
•5. Glasgow Coma Score (GCS) less than 6 at randomisation
•6. Secondary space-occupying haemorrhage in the area of infarction (PH2)
•7. Known systemic bleeding disorder or coagulation disorder
•8. Life expectancy less than 3 years
•9. Other concomitant severe disease that would confound with treatment
•10. Other clear contraindication for treatment
•11. Pregnancy

发起方

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)