The Journal of bone and joint surgery. American volume
-
J Bone Joint Surg Am · Jan 1996
Randomized Controlled Trial Multicenter Study Clinical TrialThe effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation. The American Erythropoietin Study Group.
Two hundred patients who were scheduled for a major elective orthopaedic operation were enrolled in a prospective study and were randomly assigned to one of three treatment groups. Group 1 consisted of sixty patients who received recombinant human erythropoietin, 300 international units per kilogram of body weight per day; Group 2, seventy-one patients who received recombinant human erythropoietin, 100 international units per kilogram of body weight per day; and Group 3, sixty-nine patients who received a placebo. A total of fifteen doses was given subcutaneously, beginning ten days before the operation and extending through the fourth postoperative day. ⋯ For patients who had a baseline hemoglobin level of more than 130 grams per liter, the two doses of recombinant human erythropoietin produced 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 contrast to a rate of transfusion of 36 per cent (fourteen) in Group 3 (the patients who received the placebo) (p = 0.03). The recombinant human 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 (18.93/10.40 kilopascals) to a level of 220/100 millimeters of mercury (29.33/13.33 kilopascals), after ten days of treatment with the higher dose. These data suggest that recombinant human erythropoietin, administered before and after major orthopaedic operations, can minimize the need for homologous red-blood-cell transfusion.