Condition category
Circulatory System
Date applied
16/06/2005
Date assigned
24/08/2005
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hartstichting.nl

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes