RANDOMIZED STUDY TO COMPARE THE SAFETY AND EFFICACY OF PREOPERATIVE EPOETIN A IN PATIENTS UNDERGOING MAJOR ORTHOPAEDIC SURGERY.

Abstract

Major Orthopaedic procedures frequently require pre-operative transfusion of allogeneic blood. A randomized study was conducted comparing the safety and efficacy of epoetin alfa in patients with hemoglobin levels > /10 to /< 13g/dl scheduled to undergo major elective orthopaedic arthroplasty.

106 patients scheduled for major elective orthopaedic surgery involving hip or knee replacement between 1998–2000. 83 Females and 23 males, mean age 73 years. The criteria were a) preoperative Hb level > /10 to /< 13, b)age50–85, c)ferritine > /50mg/dl d)good general health and normal Fe levels. The exclusion criteria included clinically significant systemic disease or laboratory chemistry abnormalities. The patients here divided in two matched groups of 53 Group A patients received 4 dose of 40.000IU Epoetin alfa on days -8,-4 prior to surgery and on days -l,-4 postoperatively. Group B patients received placebo the same days with group A. We performed 73 THR and 32TKRA11 patients received oral iron (150mg elemental iron) starting on the first day of study medication and continuing until hospital discharge.

In group A the mean Hb level was 12,55g/dl on the 8th preoperative day, 10,49g/dl on the 1st postoperative day and 10,37g/dl on the 7th postoperative day. In group B the mean Hb level was!3,36g/dl the 8th preoperative day, 1 l,06g/dl on the 1st postoperative day and 10,31g/dl on the 7th postoperative day. The percentage change in hemoglobin between the baseline measurement and the 7th postoperative day was -16,21 for group A and -22,13 for group B which was a statically significant difference (P=0,011).A mean of 1,49-+1,3 unit of allergenic blood was transfused in Epoetin alfa treated group compared with 2-+1,1 in the placebo group. The difference was statically significant (P=0,019) We had no complication.

These data suggest that the human erythropoietin, administered in 2 dose of 40.000 IU before and in 2 dose 40.000 IU after major orthopaedic operations can minimize the need for allogeneic blood transfusion.