Autologous blood donation plus epoetin alfa in nonanemic orthopedic surgery patients.

Intravenous (i.v.) administration of epoetin alfa facilitates the collection of autologous blood (AB) prior to elective orthopedic surgery. However, the optimum dose and dosage regimen remains to be defined. The aim of this multicenter, randomized, placebo-controlled study was to determine the optimum i.v. dose of epoetin alfa (300 IU/kg or 600 IU/kg) that would allow nonanemic patients to donate > or = 4 units of AB within 14 to 21 days of elective orthopedic surgery. All patients (n = 103) received oral iron supplementation and were treated with epoetin alfa or placebo three times during 1 week, within 3 weeks of surgery. Eighty patients were evaluable in the efficacy analysis. Compared with placebo, significantly more evaluable patients treated with epoetin alfa were able to donate > or = 4 AB units. Furthermore, epoetin alfa dose-dependently increased the preoperative reticulocyte count and attenuated the decrease in hematocrit associated with AB predonation. There was no significant difference with respect to allogeneic blood exposure between the epoetin alfa and placebo treatment groups. In addition, the 600 IU/kg dose was not significantly more effective than the 300 IU/kg dose for most efficacy parameters assessed. Several patients became iron-deficient, suggesting that oral supplementation is not an adequate source of iron in these patients. Epoetin alfa 300 IU/kg therefore appears to be the optimum i.v. dose for facilitating the collection of > or = 4 units of AB within 14 to 21 days of elective orthopedic surgery.