The Italian Acute Stroke Study Hemodilution (I.A.S.S.-H.) recruits 1,200 patients with recent (12 hrs) acute stroke admitted to university-hospital departments of neurology in Italy. The patients, randomized centrally by telephone, are allocated as follows: 50% to the treated group (hemodilution treatment) and 50% to the control group (standard treatment). Randomization is stratified by centers and severity of neurological deficit on admission.
Hemodilution treatment is performed by venesection and infusion of dextran 40; standard treatment will be provided by each Center within a common general regimen. At the end of six months the Clinical Coordination Center collects the follow-up data on mortality and disability by telephone. Hemodilution treatment will be considered of benefit if it reduces significantly mortality and disability risk, compared with the control group.