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A multicenter trial to document the efficacy and safety of a rapidly excreted analog of hydroxyethyl starch for leukapheresis with a note on steroid stimulation of granulocyte donors

Currently, the frequency of granulocyte donation is limited by the prolonged circulation of hydroxyethyl starch (HES). We conducted a Phase I, uncontrolled, multicenter trial to evaluate both the efficacy and safety of a rapidly excreted low‐molecular‐weight analog of HES (LMW‐HES). Seventy‐five donors underwent 179 centrifugation leukapheresis procedures using LMW‐HES as the red‐cell‐sedimenting agent. The efficacy of LMW‐HES was established by harvesting adequate numbers of leukocytes. Most granulocyte concentrates contained at least 20 × 109 neutrophils when 8 I of blood was processed from donors optimally stimulated with steroids. The safety of LMW‐HES was documented by the detection of almost no clinically significant adverse effects. In only 1.7 percent of procedures did donors require special attention, and only 1 of 179 procedures (0.6%) was permanently discontinued. Results of laboratory studies were usually normal or their values decreased transiently (approximately 15–25%) as a consequence of plasma volume expansion (dilution). Based on previous experience with HES, LMW‐HES and HES perform comparably during leukapheresis. When commercially available, use of this new, rapidly excreted analog should permit more frequent leukapheresis donation.