Erythropoietin with iron supplementation to prevent allogeneic blood transfusion in total hip joint arthroplasty - A randomized, controlled trial

Background: The optimum regimen of epoetin alfa for prevention of allogenei c blood transfusion is unknown. Objective: To determine whether a modified regimen of epoetin alfa reduces allogeneic blood transfusion in patients undergoing hip arthroplasty. Design: Randomized, double-blind, multicenter trial comparing two modified dose regimens of epoetin alfa with placebo. Setting: 13 teaching hospitals and 4 community hospitals in Canada. Patients: 201 patients undergoing primary hip arthroplasty who had a hemogl obin concentration of 98 to 137 g/L and did not predonate blood. Intervention: Patients were assigned in a 3:5:5 ratio to receive four weekl y doses of epoetin alfa, 40 000 U (high-dose; n = 44) or 20 000 U (low-dose ; n = 79), or placebo (n = 78), starting 4 weeks before surgery. All patien ts received oral iron supplementation, 450 mg/d, for 42 or more days before surgery. Measurements: The primary end point was allogeneic transfusion. Secondary e nd points were thromboembolic events and change in reticulocyte count and h emoglobin concentration. Results: Both modified epoetin alfa regimens significantly reduced the need for allogeneic transfusion: Five (11.4%) patients in the high-dose group ( P = 0.001) and 18 (22.8%) patients in the low-dose group (P = 0.003) had tr ansfusion, compared with 35 (44.9%) patients in the placebo group. The hema tologic response was substantial in patients who received epoetin alfa. In the high-dose group, low-dose group, and placebo group, the preoperative in crease in reticulocyte count was 58.8, 37.0 and 1.8 x 10(9) cells/L (P < 0. 004), respectively, and the increase in hemoglobin concentration was 19.5, 17.2, and 1.2 g/L (P < 0.001). The incidence of thromboembolic events did n ot differ among groups. Conclusions: Both modified epoetin alfa regimens were effective compared wi th placebo in reducing allogeneic transfusion in patients undergoing hip ar throplasty. Patients who received high-dose epoetin alfa had the lowest tra nsfusion rate.