Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial

ISRCTN ISRCTN94237756
DOI https://doi.org/10.1186/ISRCTN94237756
Secondary identifying numbers 2002B138
Submission date
16/06/2005
Registration date
24/08/2005
Last edited
06/01/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hendrik Bernardus van der Worp
Scientific

P.O. Box 85500
HP G.03.228
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 2509111
Email h.b.vanderworp@umcutrecht.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHAMLET
Study objectivesIn 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(s)Approved by the medical ethical committees of all participating centres.
Health condition(s) or problem(s) studiedIschaemic stroke; space-occupying hemispheric infarction
InterventionPatients 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 typeOther
Primary outcome measureScore on the modified Rankin Scale (mRS) at one year
Secondary outcome measuresThe 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 study start date01/09/2002
Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants112
Key inclusion criteriaPatients 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
Key exclusion criteriaPatients 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
Date of first enrolment01/09/2002
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor information

Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Research organisation

P.O. Box 300
The Hague
2501 CH
Netherlands

Email info@hartstichting.nl
Website http://www.hartstichting.nl
ROR logo "ROR" https://ror.org/05nxhgm70

Funders

Funder type

Research organisation

Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B138)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/09/2006 Yes No
Results article results 01/05/2013 Yes No
Results article results 01/09/2013 Yes No
Results article results 01/10/2013 Yes No