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 allogeneic blood transfusion is unknown.


OBJECTIVE
To determine whether a modified regimen of epoetin alfa reduces allogeneic blood transfusion in patients undergoing hip arthroplasty.


METHODS
Randomized, double-blind, multicenter trial comparing two modified dose regimens of epoetin alfa with placebo.


METHODS
13 teaching hospitals and 4 community hospitals in Canada.


METHODS
201 patients undergoing primary hip arthroplasty who had a hemoglobin concentration of 98 to 137 g/L and did not predonate blood.


METHODS
Patients 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.


METHODS
The primary end point was allogeneic transfusion. Secondary end points were thromboembolic events and change in reticulocyte count and hemoglobin 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 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.


CONCLUSIONS
Both 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.
Feagan
B G
BG
London Clinical Trials Research Group, The John P. Robarts Research Institute, Box 5015, 100 Perth Drive, London, Ontario N6A 5K8, Canada.
Wong
C J
CJ
Kirkley
A
A
Johnston
D W
DW
Smith
F C
FC
Whitsitt
P
P
Wheeler
S L
SL
Lau
C Y
CY
D000368:Aged; D001803:Blood Transfusion; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006397:Hematinics / Q000008:administration & dosage*; D006452:Hemoglobinometry; D006801:Humans; D007501:Iron / Q000008:administration & dosage* / Q000097:blood; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011134:Polysaccharides / Q000008:administration & dosage*; D011655:Pulmonary Embolism / Q000209:etiology; D011994:Recombinant Proteins; D017701:Reticulocyte Count; D065227:Transfusion Reaction; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000209:etiology
D006397:Hematinics; D011134:Polysaccharides; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; C078972:Niferex; D007501:Iron