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

Jeannette Hofmeijer¹^,2 , G Johan Amelink¹^,2 , Ale Algra¹^,2 , Jan van Gijn¹^,2 , Malcolm R Macleod¹^,2 , L Jaap Kappelle¹^,2 and H Bart van der Worp¹^,2 for the HAMLET investigators¹^,2

¹Departments of Neurology (JH, AA, JvG, LJK, and HBvdW), Neurosurgery (GJA), and Julius Centre for Health Sciences and Primary Care (AA), University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands

²School of Molecular and Clinical Medicine, University of Edinburgh, Edinburgh (MMM), UK

author email corresponding author email

Trials 2006, 7:29doi:10.1186/1745-6215-7-29


Published:	11 September 2006

Abstract

Background

Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction

Methods

The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.