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Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2
DOI 10.1186/ISRCTN21702227
ClinicalTrials.gov identifier
EudraCT number
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 Not provided at time of registration
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 Completed
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 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21205246
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645942
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
  Email 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
  Email postmaster@dfg.de
  Sponsor website: http://www.dfg.de/
Date applied 14/01/2009
Last edited 27/03/2014
Date ISRCTN assigned 05/02/2009
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