Malignant middle cerebral artery infarction Surgery Malignant infarction of the middle cerebral artery
Conditions
Interventions
Decompressive surgery (the following protocol is a consensus protocol that was worked out by Prof Unterberg (Department of Neurosurgery, University of Heidelberg) as a written paper and as a video and
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome after six months measured by the modified Rankin Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Amended 25/11/10: 1. Mortality after 30 days, 1, 2, 3, 4 and 5 years 2. Functional outcome after 1, 2, 3, 4 and 5 years 3. Retrospective agreement to the procedure by the patients and caregivers after 1, 2, 3, 4 and 5 years All other outcomes remain unchanged. Current information as of 09/02/10: 1. Mortality after 30 days, 1, 2, 3 and 4 years 2. Functional outcome after 1, 2, 3, and 4 years, measured by the following: 2.1. Modified Rankin Scale 2.2. National Institutes of Health Stroke Scale (NIHSS) 2.3. Barthel Index 2.4. Stroke Impact Scale (SIS) 2.5. SF-36® Health Survey 2.6. Aachen Aphasia Inventory 3. Retrospective agreement to the procedure by the patients and caregivers after 1, 2, 3, and 4 years 4. Complications related to surgery 5. Infarct size after days 2-3 and 4-8, measured by computerised tomography Current information as of 09/01/2009: 1. Mortality after 30 days, 12 and 36 months 2. Functional outcome after 12 and 36 months, measured by the following: 2.1. Modified Rankin Scale 2.2. National Institutes of Health Stroke Scale (NIHSS) 2.3. Barthel Index 2.4. Stroke Impact Scale (SIS) 2.5. SF-36® Health Survey 3. Retrospective agreement to the procedure by the patients and caregivers 4. Complications related to surgery 5. Infarct size after days 2-3 and 4-8, measured by computerised tomography Initial information at time of registration: 1. Mortality after 30 days 2. Mortality after 12 months 3. Functional outcome after 12 months measured by the following: 3.1. Modified Rankin Scale 3.2. National Institutes of Health Stroke Scale (NIHSS) 3.3. Barthel Index 3.4. SF-36® Health Survey 4. Complications related to surgery 5. Infarct size after days 2-3 and 4-8, measured by computerised tomography | — |
Countries
Germany
Outcome results
None listed