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Randomized Controlled Trial Multicenter Study Clinical Trial
Erythropoietin with iron supplementation to prevent allogeneic blood transfusion in total hip joint arthroplasty. A randomized, controlled trial.
- B G Feagan, C J Wong, A Kirkley, D W Johnston, F C Smith, P Whitsitt, S L Wheeler, and C Y Lau.
- London Clinical Trials Research Group, The John P. Robarts Research Institute, Box 5015, 100 Perth Drive, London, Ontario N6A 5K8, Canada.
- Ann. Intern. Med. 2000 Dec 5; 133 (11): 845-54.
BackgroundThe optimum regimen of epoetin alfa for prevention of allogeneic blood transfusion is unknown.ObjectiveTo determine whether a modified regimen of epoetin alfa reduces allogeneic blood transfusion in patients undergoing hip arthroplasty.DesignRandomized, double-blind, multicenter trial comparing two modified dose regimens of epoetin alfa with placebo.Setting13 teaching hospitals and 4 community hospitals in Canada.Patients201 patients undergoing primary hip arthroplasty who had a hemoglobin concentration of 98 to 137 g/L and did not predonate blood.InterventionPatients were assigned in a 3:5:5 ratio to receive four weekly 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 patients received oral iron supplementation, 450 mg/d, for 42 or more days before surgery.MeasurementsThe primary end point was allogeneic transfusion. Secondary end points were thromboembolic events and change in reticulocyte count and hemoglobin concentration.ResultsBoth 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 transfusion, compared with 35 (44.9%) patients in the placebo group. The hematologic response was substantial in patients who received epoetin alfa. In the high-dose group, low-dose group, and placebo group, the preoperative increase in reticulocyte count was 58.8, 37. 0 and 1.8 x 10(9) cells/L (P < 0.001), 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 not differ among groups.ConclusionsBoth modified epoetin alfa regimens were effective compared with placebo in reducing allogeneic transfusion in patients undergoing hip arthroplasty. Patients who received high-dose epoetin alfa had the lowest transfusion rate.
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