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.