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ISRCTN
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ISRCTN94237756
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ClinicalTrials.gov identifier
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Public title
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Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial
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Scientific title
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Acronym
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HAMLET
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Serial number at source
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2002B138
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Study hypothesis
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In patients with space-occupying hemispheric infarction, decompressive surgery not only reduces mortality substantially, but also improves functional outcome in survivors, as compared with conservative treatment.
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Lay summary
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Ethics approval
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Approved by the medical ethical committees of all participating centres.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Ischaemic stroke; space-occupying hemispheric infarction
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Participants - inclusion criteria
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Patients may be enrolled in the study if all of the following criteria are met:
1. Diagnosis of acute ischaemic stroke in the territory of the middle cerebral artery, with an onset within 96 hours prior to the planned start of the trial treatment
2. Score on the National Institutes of Health Stroke Scale (NIHSS) greater than or equal to 16 for right-sided lesions or greater than or equal to 21 for left-sided lesions
3. Gradual decrease in consciousness to a score of 13 or lower on the Glasgow Coma Scale (GCS) for right-sided lesions, or an eye and motor score of 9 or lower for left-sided lesions
4. Ischaemic changes on computed tomography (CT) involving two thirds or more of the territory of the middle cerebral artery (MCA), and space-occupying oedema formation. Displacement of midline structures on CT is not a requirement for inclusion.
5. Age 18 up to and including 60 years
6. Possibility to start trial treatment within 3 hours after randomisation
7. Written informed consent by a representative of the patient
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Participants - exclusion criteria
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Patients will be excluded from the study for any of the following reasons:
1. Ischaemic stroke of the entire cerebral hemisphere (anterior, middle, and posterior cerebral artery territories)
2. Decrease in consciousness (partially) explained by a cause other than oedema formation, such as metabolic disturbances or medication
3. Two fixed dilated pupils
4. Treatment with a thrombolytic agent in the 12 hours preceding randomisation
5. Known systemic bleeding disorder
6. Pre-stroke score on the modified Rankin Scale greater than 1 or less than 95 on the Barthel Index
7. Life expectancy less than 3 years
8. Other serious illness that may confound treatment assessment
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Anticipated start date
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01/09/2002
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Anticipated end date
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01/10/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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112
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Interventions
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Patients will be randomised to either surgical or conservative treatment. Randomisation will be stratified for the intended mode of conservative treatment (intensive care versus stroke unit care; see below). The choice of conservative treatment is left at the discretion of the local investigator, but will usually depend on the standard mode of treatment in the participating centre. Decompressive surgery will consist of a large hemicraniectomy and a duraplasty.
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Primary outcome measure(s)
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Score on the modified Rankin Scale (mRS) at one year
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Secondary outcome measure(s)
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The scores on the NIH Stroke Scale (NIHSS), the Barthel Index (BI), and the Montgomery and Asberg Depression Rating Scale (MADRS) and quality of life as measured with the SF36 and a visual analogue scale (VAS) at one year. In addition, the mRS, NIHSS, and BI will also be determined at 3 and 6 months, and the mRS, BI, MADRS, and SF36 also at 3 years after randomisation.
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Sources of funding
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Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B138)
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Trial website
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Publications
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2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16965617
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Contact name
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Dr
Hendrik Bernardus
van der Worp
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Address
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P.O. Box 85500
HP G.03.228
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Tel
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+31 (0)30 2509111
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Fax
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+31 (0)30 2522782
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Email
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h.b.vanderworp@umcutrecht.nl
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Sponsor
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Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
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Address
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P.O. Box 300
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City/town
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The Hague
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Zip/Postcode
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2501 CH
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Country
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Netherlands
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Email
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info@hartstichting.nl
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Sponsor website:
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http://www.hartstichting.nl
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Date applied
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16/06/2005
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Last edited
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13/05/2009
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Date ISRCTN assigned
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24/08/2005
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