Placebo-Controlled, Double-Blind Trial of Hemodilution in Peripheral Occlusive Arterial Disease

Abstract

A number of uncontrolled trials has suggested that hemodilution is effective in peripheral occlusive arte rial disease. This study was aimed at proving or disproving the efficacy of hemodilution by using a randomized, placebo-controlled, double-blind crossover design. Twenty-four stable claudicants with long, collateralized femoropopliteal obstructions were treated with isovolemic hemodilution with 500 mL of 10% hydroxyethyl starch 200 and sham dilutions. Three weeks of hemodilution lowered blood and plasma viscosity, as well as hema tocrit, and increased resting blood flow and pain-free walking distance. Placebo treatments produced no such favorable changes. It is concluded that hemodilution therapy can be clinically effective in patients with ar terial obstructions in the lower ex tremities. Hemodilution seems particularly promising under hemo dynamic condition of low shear stresses in vivo.