Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dfg.de/

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

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21205246
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645942

Publication citations

  1. 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.

  2. 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.

Editorial Notes