Contact information
Type
Scientific
Primary contact
Dr Hendrik Bernardus van der Worp
ORCID ID
Contact details
P.O. Box 85500
HP G.03.228
Utrecht
3508 GA
Netherlands
+31 (0)30 2509111
h.b.vanderworp@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2002B138
Study information
Scientific title
Acronym
HAMLET
Study hypothesis
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.
Ethics approval
Approved by the medical ethical committees of all participating centres.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ischaemic stroke; space-occupying hemispheric infarction
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Score on the modified Rankin Scale (mRS) at one year
Secondary outcome measures
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.
Overall trial start date
01/09/2002
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
112
Participant exclusion criteria
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
Recruitment start date
01/09/2002
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Sponsor details
P.O. Box 300
The Hague
2501 CH
Netherlands
info@hartstichting.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B138)
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
2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16965617
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23868265
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23943217
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23306601
Publication citations
-
Protocol
Hofmeijer J, Amelink GJ, Algra A, van Gijn J, Macleod MR, Kappelle LJ, van der Worp HB, , Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction., Trials, 2006, 7, 29, doi: 10.1186/1745-6215-7-29.
-
Results
Geurts M, van der Worp HB, Kappelle LJ, Amelink GJ, Algra A, Hofmeijer J, , Surgical decompression for space-occupying cerebral infarction: outcomes at 3 years in the randomized HAMLET trial., Stroke, 2013, 44, 9, 2506-2508, doi: 10.1161/STROKEAHA.113.002014.
-
Results
Hofmeijer J, van der Worp HB, Kappelle LJ, Eshuis S, Algra A, Greving JP, , Cost-effectiveness of surgical decompression for space-occupying hemispheric infarction., Stroke, 2013, 44, 10, 2923-2925, doi: 10.1161/STROKEAHA.113.002445.
-
Results
Hofmeijer J, van der Worp HB, Kappelle LJ, Amelink GJ, Algra A, van Zandvoort MJ, Cognitive outcome of survivors of space-occupying hemispheric infarction., J. Neurol., 2013, 260, 5, 1396-1403, doi: 10.1007/s00415-012-6810-1.