An open-label, randomized study to compare the safety and efficacy of perioperative epoetin alfa with preoperative autologous blood donation in totaljoint arthroplasty

A multicenter, randomized, open-label, parallel-group study was conducted t o compare the safety and efficacy of perioperative recombinant human erythr opoietin (Epoetin alfa) with the safety and efficacy of preoperative autolo gous donation(PAD) in total joint arthroplasty. A total of 490 patients sch eduled for total joint (i.e., hip or knee) surgery and having hemoglobin (H b) levels greater than or equal to 11 to less than or equal to 13 g/dL were randomized to receive weekly doses of subcutaneous Epoetin alfa on preoper ative Days -21, -14, and -7, and on the day of surgery, or to participate i n a PAD program. The mean baseline Hb level in both groups was 12.3 +/- 0.6 g/dL, increasing to 13.8 g/dL in the Epoetin alfa-treated group and decrea sing to 11.1 g/dL in the PAD group before or on the day of surgery. In the PAD group, 156/219 (71.2%) patients were transfused with autologous blood, and 42/219 (19.2%) patients were transfused with allogeneic blood. A smalle r proportion, 27/209 (12.9%) patients, in the Epoetin alfa-treated group we re transfused with allogeneic blood (P = .078 compared with the PAD group). Moreover, patients in the PAD group received a total of 325 units of blood (79 allogeneic units and 246 autologous units) compared with patients in t he Epoetin alfa group who received a total of 54 units of blood. The mean p ostoperative Hb level was 11.0 g/dL in the Epoetin alfa-treated group and 9 .2 g/dL in the PAD group. Compared with the PAD arm, mean Hb levels measure d preoperatively, postoperatively on Day 1, and at discharge visits were si gnificantly greater in the Epoetin alfa-treated arm (P < .0001).