Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2

Completed

• Conditions: Malignant space-occupying middle cerebral artery infarction; Circulatory System; Cerebral infarction

• Registration Number: ISRCTN21702227
• Lead Sponsor: German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale score, dichotomised 0 - 4 versus 5 - 6 after 6 months.

Secondary Outcome Measures

Name	Time	Method
1. Median time of survival after 1 year<br>2. Mortality after 1 year<br>3. NIHSS score after 1 year<br>4. mRS score after 1 year<br>5. mRS score, dichotomised 0 - 3 versus 4 - 6 after 1 year<br>6. Barthel-Index after 1 year<br>7. Stroke Impact Scale after 1 year<br>8. Aachen Aphasia Test after 1 year<br>9. Hamilton Depression Scale after 1 year<br>10. Complications related to surgery after 1 year