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| [ ...Back to search results ] | [ Print-friendly version ] |
| Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2 |
| ISRCTN | ISRCTN21702227 |
| ClinicalTrials.gov identifier | |
| Public title | Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2 |
| Scientific title | Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2: a prospective randomised open controlled multicentre comparative trial |
| Acronym | DESTINY 2 |
| Serial number at source | Version 1 |
| Study hypothesis | In patients older than 60 years with space-occupying malignant supra-tentorial ischaemic infarcts, decompressive hemicraniectomy significantly decreases mortality or very severe disability, and improves disability, functional neurological deficit, and quality of life compared to conservative intensive care treatment. |
| Lay summary | |
| Ethics approval | Submitted to Ethical Committee I, Medical Faculty, University of Heidelberg (Ethikkommission I der Medizinischen Facultat, Universitat Heidelberg), is expected to pass in February/March 2009 |
| Study design | Prospective randomised open controlled multicentre phase III comparative trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Malignant space-occupying middle cerebral artery infarction |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/03/2009 |
| Anticipated end date | 01/01/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Maximum of 160 |
| Interventions |
1. Decompressive hemicraniectomy
2. Conservative intensive-care medical treatment The total duration of treatment is individual, usually less than 2 weeks, but may be longer. The last follow-up will be after 1 year for all arms. |
| Primary outcome measure(s) | Modified Rankin Scale score, dichotomised 0 - 4 versus 5 - 6 after 6 months. |
| Secondary outcome measure(s) |
1. Median time of survival after 1 year
2. Mortality after 1 year 3. NIHSS score after 1 year 4. mRS score after 1 year 5. mRS score, dichotomised 0 - 3 versus 4 - 6 after 1 year 6. Barthel-Index after 1 year 7. Stroke Impact Scale after 1 year 8. Aachen Aphasia Test after 1 year 9. Hamilton Depression Scale after 1 year 10. Complications related to surgery after 1 year |
| Sources of funding | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: JU 2764/1-1) |
| Trial website | |
| Publications | 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21205246 |
| Contact name | Dr Eric Juettler |
| Address |
University of Heidelberg
Im Neuenheimer Feld 400 |
| City/town | Heidelberg |
| Zip/Postcode | D-69120 |
| Country | Germany |
| Tel | +49 (0)6221 56 38155 |
| Fax | +49 (0)6221 56 5461 |
| eric.juettler@med.uni-heidelberg.de | |
| Sponsor | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
| Address | Kennedyallee 40 |
| City/town | Bonn |
| Zip/Postcode | D-53175 |
| Country | Germany |
| Tel | +49 (0)0228/885-1 |
| Fax | +49 (0)0228/885-2777 |
| postmaster@dfg.de | |
| Sponsor website: | http://www.dfg.de/ |
| Date applied | 14/01/2009 |
| Last edited | 02/02/2011 |
| Date ISRCTN assigned | 05/02/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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