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 X 10(9) neutrophils when 8 l 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.
R G
RG
Strauss
J P
JP
Hester
W R
WR
Vogler
D J
DJ
Higby
A C
AC
Snikeris
K M
KM
Imig
C
C
Greazel
G
G
Mallard
D
D
Burnett
S
S
Gupta
D000305:Adrenal Cortex Hormones / Q000494:pharmacology; D006098:Granulocytes / Q000637:transplantation*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000031:analogs & derivatives*; D007937:Leukapheresis / Q000379:methods*; D008970:Molecular Weight; D013213:Starch / Q000031:analogs & derivatives*
D000305:Adrenal Cortex Hormones; D006895:Hydroxyethyl Starch Derivatives; D013213:Starch