Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery

Completed

• Conditions: Malignant middle cerebral artery infarction; Surgery; Malignant infarction of the middle cerebral artery

• Registration Number: ISRCTN01258591
• Lead Sponsor: niversity of Heidelberg (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Age 18 up to and including 60 years
2. Clinical signs of an ischemic infarction of the middle cerebral artery with a score on the National Institutes of Health Stroke Scale (NIHSS) >18 for lesions of the non-dominant hemisphere and >20 for lesions of the dominant hemisphere
3. Neuroradiological signs of an unilateral infarction of the middle cerebral artery including at least two-thirds or more of the territory of the middle cerebral artery and including at least partly the basal ganglia, with or without an additional infarction of the anterior or posterior cerebral artery on the same side
4. Onset of symptoms before more than 12 and less than 36 hours prior to a possible surgical intervention
5. Possibility to start treatment or surgery within 6 hours after randomisation

Exclusion Criteria

1. Pre-stroke score on the modified Rankin Scale >2 or on the Barthel Index <95 (Rankin et al. 1957, Mahoney et al. 1965)
2. Glasgow Coma Scale <6 at the time of randomisation
3. Coincidental other brain lesion (i.e. trauma)
4. Two fixed dilated pupils
5. Secondary bleeding in the area of infarction
6. Known systemic bleeding disorder
7. Life expectancy <3 years
8. Other serious illness that may confound treatment assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified