The Italian hemodilution trial in acute stroke.

The Italian Acute Stroke Study is a prospective, multicenter, randomized, clinical trial to evaluate hemodilution in acute stroke. Thirty-one centers will recruit 1,200 patients with a recent (less than 12 hours) hemispheric acute stroke. Randomization is performed centrally, and patients are stratified by center and severity of neurologic deficit. Hemodilution is achieved by venesection and infusion of the same amount of dextran 40. Otherwise, both treated and control groups receive the standard treatment provided by each center within agreed guidelines. At 6 months after stroke, one member of the Clinical Coordinating Center, blind as to treatment allocation, collects data on mortality and disability by telephone. We expect to terminate the randomization on December 31, 1986, and the follow-up evaluation on June 30, 1987. The aim of the study is to evaluate whether mortality and disability are significantly reduced in the group treated with hemodilution compared with the control group.