THE EFFECTS OF RECOMBINANT-HUMAN-ERYTHROPOIETIN ON PERIOPERATIVE TRANSFUSION REQUIREMENTS IN PATIENTS HAVING A MAJOR ORTHOPEDIC OPERATION

Two hundred patients who were scheduled for a major elective orthopaed ic operation were enrolled in a prospective study and were randomly as signed to one of three treatment groups. Group 1 consisted of sixty pa tients who received recombinant human erythropoietin, 300 internationa l units per kilogram of body weight per day; Group 2, seventy-one pati ents who received recombinant human erythropoietin, 100 international units per kilogram of body weight per day; and Group 3, sixty-nine pat ients who received a placebo. A total of fifteen doses was given subcu taneously, beginning ten days before the operation and extending throu gh the fourth postoperative day. Patients who declined or were unable to donate autologous blood preoperatively were included in the study a nd were maintained on iron supplementation orally. The decision to tra nsfuse red blood cells depended on the physician; however, physicians were encouraged not to do so if the hematocrit was more than 0.27 (27 per cent), unless the clinical symptoms warranted it. Of the 185 patie nts who were evaluable with regard to efficacy, significantly fewer pa tients received homologous red-blood-cell transfusions in Groups 1 and 2 (17 per cent [nine] and 25 per cent [sixteen], respectively) than i n Group 3 (54 per cent [thirty-six]) (p < 0.001). When the patients we re stratified into two groups on the basis of the pre-treatment hemogl obin level (more than 100 to 130 grams per liter or more than 130 gram s per liter), we found that patients who had received a placebo and ha d a baseline hemoglobin level of more than 100 to 130 grams per liter were at significantly higher risk for transfusion (78 per cent [twenty -one]) than those who had received a placebo and had a baseline level of more than 130 grams per liter (36 per cent [fourteen]). For patient s who had a baseline hemoglobin level of more than 100 to 130 grams pe r liter, the higher dose of recombinant human erythropoietin appeared somewhat more effective than the lower dose, with 14 per cent (three) of the patients in Group 1 and 39 per cent (nine) in Group 2 needing a transfusion; however, the difference was not significant (p = 0.09). For patients who had a baseline hemoglobin level of more than 130 gram s per liter, the two doses of recombinant human erythropoietin produce d similar results, with 14 per cent (four) of the patients in Group 1 and 11 per cent (four) in Group 2 needing a transfusion; this was in c ontrast to a rate of transfusion of 36 per cent (fourteen) in Group 3 (the patients who received the placebo) (p = 0.03). The recombinant hu man erythropoietin was generally well tolerated, although one patient, who did not have a history of hypertension, had an increase in blood pressure, from a baseline level of 142/78 millimeters of mercury (18.9 3/10.40 kilopascals) to a level of 220/100 millimeters of mercury (29. 33/13.33 kilopascals), after ten days of treatment with the higher dos e. These data suggest that recombinant human erythropoietin, administe red before and after major orthopaedic operations, can minimize the ne ed for homologous red-blood-cell transfusion.