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

ISRCTN	ISRCTN21702227
DOI	https://doi.org/10.1186/ISRCTN21702227
Protocol serial number	Version 1
Sponsor	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Funder	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: JU 2764/1-1)

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

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

Study information

Primary study design	Interventional
Study design	Prospective randomised open controlled multicentre phase III comparative trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Decompressive surgery for the treatment of malignant infarction of the middle cerebral artery 2: a prospective randomised open controlled multicentre comparative trial
Study acronym	DESTINY 2
Study objectives	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.
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) studied	Malignant space-occupying middle cerebral artery infarction
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Modified Rankin Scale score, dichotomised 0 - 4 versus 5 - 6 after 6 months.
Key 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
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	01/03/2009
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

Germany

Study participating centre

University of Heidelberg

Heidelberg
D-69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/03/2014		Yes	No
Protocol article	protocol	01/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes