title: 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.
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.
authors.affiliation: Department of Neurology, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands. j.hofmeijer@umcutrecht.nl
authors.forename: Jeannette
authors.initials: J
authors.lastname: Hofmeijer
authors.forename: G Johan
authors.initials: GJ
authors.lastname: Amelink
authors.forename: Ale
authors.initials: A
authors.lastname: Algra
authors.forename: Jan
authors.initials: J
authors.lastname: van Gijn
authors.forename: Malcolm R
authors.initials: MR
authors.lastname: Macleod
authors.forename: L Jaap
authors.initials: LJ
authors.lastname: Kappelle
authors.forename: H Bart
authors.initials: HB
authors.lastname: van der Worp