Evaluation of long-term outcome and safety after hemodilution therapy in acute ischemic stroke.

BACKGROUND AND PURPOSE In a previous single-center, randomized controlled trial including 102 patients treated in a stroke unit, we showed that rapid, modest hemodilution improved short-term clinical outcome in ischemic stroke patients. I now evaluate the long-term outcome and potential risks of this combined venesection/dextran 40 therapy in the same 52 treated and 50 control patients. METHODS Mortality, need for institutional care, and recurrent strokes were registered during 1 year following inclusion in the trial, and a final evaluation of functional outcome was performed at 12 months after the stroke. Cerebrospinal fluid was analyzed for protein content and hemorrhagic admixture at two occasions during the acute phase. RESULTS Thirty-six hemodiluted and 30 control patients survived the first year following the stroke (difference not significant). One year after the stroke, persistent neurological deficits were less frequent among the hemodiluted patients and a larger proportion of hemodiluted survivors was independent in walking (92% versus 73%, p less than 0.05). Two hemodiluted patients (6%) and nine control patients (30%) were totally dependent in the activities of daily living (p less than 0.05). Three hemodiluted patients (8%) and eight control patients (27%) remained hospitalized 1 year after the stroke (p less than 0.05). With the possible exception of patients with a medical history of congestive heart failure, subset analyses revealed a tendency toward improved outcome for hemodiluted patients in all clinically important subgroups compared with the controls. When analyzing cerebrospinal fluid, signs of blood-brain barrier breakdown and hemorrhagic admixture to the cerebrospinal fluid during the acute phase were less frequent in the hemodiluted subjects. CONCLUSIONS These results suggest that, when applied in a stroke unit, the combination of venesection and dextran 40 administration is a clinically safe, therapeutic regimen in the treatment of acute cerebral infarction that improves long-term clinical outcome.