EFFECTIVENESS OF VERY-LOW DOSES OF SUBCUTANEOUS RECOMBINANT-HUMAN-ERYTHROPOIETIN IN FACILITATING AUTOLOGOUS BLOOD DONATION BEFORE ORTHOPEDIC-SURGERY

Background: Clinical and pharmacokinetic data suggest that very low do ses of subcutaneous recombinant human erythropoietin (rHuEPO) may be e ffective in a preoperative autologous blood deposit program. Study Des ign and Methods: Fifty-two patients, scheduled for orthopedic surgery, were enrolled in a double-blind and placebo-controlled study, Patient s were randomly assigned to the placebo group or to receive 30, 60, or 100 IU per kg of rHuEPO subcutaneously twice a week for 2 weeks befor e surgery. The dose of rHuEPO that was effective in facilitating the c ollection of 4 units of blood in the 2 weeks before surgery and that p revented a sharp decrease in hematocrit was determined. Results: Only in patients receiving 100 IU per kg of rHuEPO did the outcome measurem ents differ significantly from those in the placebo group. With a high er (p<0.01) cumulative increase in red cell volume during the study pe riod (297 +/- 127 vs. 121 +/- 44 mL), 64 percent of those receiving 10 0 IU per kg of rHuEPO were able to donate 4 units of blood for autolog ous use, as compared with 23 percent of the placebo group (p<0.05). Al logeneic transfusion was avoided, and the preoperative hematocrit and reticulocyte count were significantly higher in the patients receiving 100 IU per kg of rHuEPO (p<0.05 and p<0.01, respectively). Conclusion : Subcutaneously administered rHuEPO at a dose of 100 IU per kg twice a week for 2 weeks is effective in facilitating the collection of bloo d for autologous use and may improve the cost-benefit ratio of blood c onservation interventions. Doses less than or equal to 60 IU per kg ar e ineffective in facilitating such collections in this surgical settin g.