Contact information
Type
Scientific
Primary contact
Dr Eric Juettler
ORCID ID
Contact details
University of Heidelberg
Im Neuenheimer Feld 400
Heidelberg
D-69120
Germany
+49 (0)6221 56 38155
eric.juettler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measure
Modified Rankin Scale score, dichotomised 0 - 4 versus 5 - 6 after 6 months.
Secondary outcome measures
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
Overall trial start date
01/03/2009
Overall trial end date
01/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Maximum of 160
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
01/01/2013
Locations
Countries of recruitment
Germany
Trial participating centre
University of Heidelberg
Heidelberg
D-69120
Germany
Sponsor information
Organisation
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Sponsor details
Kennedyallee 40
Bonn
D-53175
Germany
+49 (0)0228/885-1
postmaster@dfg.de
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: JU 2764/1-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21205246
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645942
Publication citations
-
Protocol
Jüttler E, Bösel J, Amiri H, Schiller P, Limprecht R, Hacke W, Unterberg A, , DESTINY II: DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY II., Int J Stroke, 2011, 6, 1, 79-86, doi: 10.1111/j.1747-4949.2010.00544.x.
-
Results
Jüttler E, Unterberg A, Woitzik J, Bösel J, Amiri H, Sakowitz OW, Gondan M, Schiller P, Limprecht R, Luntz S, Schneider H, Pinzer T, Hobohm C, Meixensberger J, Hacke W, , Hemicraniectomy in older patients with extensive middle-cerebral-artery stroke., N. Engl. J. Med., 2014, 370, 12, 1091-1100, doi: 10.1056/NEJMoa1311367.