Abstract :
In a double-blind, multicenter study, 200 patients who could not or would not donate autologous blood before major orthopedic surgery requiring transfusion of at least 2 units of whole blood were randomized to receive placebo (n = 69) or recombinant human erythropoietin (Epoetin alfa) in daily doses of 300 U/kg (n = 60) or 100 U/kg (n = 71) for 15 consecutive days, starting 10 days before surgery and extending through the fourth postoperative day. Of these, 185 patients who received active medication or placebo and underwent surgery were qualified for evaluation of efficacy (n = 67, n = 54, and n = 64, respectively). All patients received concomitant oral iron supplementation. Compared with placebo-treated patients, a significantly lower proportion of patients who received either dose of Epoetin alfa required allogeneic blood transfusions (54% for placebo, 17% for 300 U/ kg, 25% for 100 U/kg; p <0.01), as well as fewer mean units of blood (1.42 units for placebo, 0.37 units for 300 U/kg, 0.58 units for 100 U/kg; p <0.01). The differences between the Epoetin alfa treatment groups were not statistically significant. On the basis of these results, perioperative Epoetin alfa therapy in conjunction with iron supplementation may have a place as an adjunct to elective orthopedic surgery, particularly if dosing regimens less frequent than once daily can be established.
