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

ISRCTN ISRCTN21702227
DOI https://doi.org/10.1186/ISRCTN21702227
Secondary identifying numbers Version 1
Submission date
14/01/2009
Registration date
05/02/2009
Last edited
27/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eric Juettler
Scientific

University of Heidelberg
Im Neuenheimer Feld 400
Heidelberg
D-69120
Germany

+49 (0)6221 56 38155
eric.juettler@med.uni-heidelberg.de

Study information

Study designProspective randomised open controlled multicentre phase III comparative trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDecompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2: a prospective randomised open controlled multicentre comparative trial
Study acronymDESTINY 2
Study objectivesIn 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.
Ethics approval(s)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
Health condition(s) or problem(s) studiedMalignant space-occupying middle cerebral artery infarction
Intervention1. 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.
Intervention typeOther
Primary outcome measureModified Rankin Scale score, dichotomised 0 - 4 versus 5 - 6 after 6 months.
Secondary outcome measures1. 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
Overall study start date01/03/2009
Completion date01/01/2013

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsMaximum of 160
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2009
Date of final enrolment01/01/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Heidelberg
Heidelberg
D-69120
Germany

Sponsor information

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Research council

Kennedyallee 40
Bonn
D-53175
Germany

+49 (0)0228/885-1
postmaster@dfg.de
http://www.dfg.de/
ROR logo https://ror.org/018mejw64

Funders

Funder type

Research council

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: JU 2764/1-1)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/02/2011 Yes No
Results article results 20/03/2014 Yes No
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