Patients undergoing orthopedic or heart and blood vessel surgery frequently require blood
transfusions both during and after the operation. Patients often have their own blood
collected for this purpose over a standard 3- to 4-week period before surgery. A large
percentage of patients are not able to pre-deposit their own blood for transfusion. For such
patients, an agent that can facilitate self-donation and reduce the need for transfusions
from others in less time than the conventional 3 weeks before surgery may improve the overall
safety of surgery. This is a randomized, double-blind, placebo-controlled, parallel group,
multicenter study to evaluate whether epoetin alfa will enable the self-deposit of at least 4
units of blood in the abbreviated presurgical time period of 2 weeks by patients who are not
anemic and who are undergoing orthopedic or heart and blood vessel surgery. The study
consists of a 7-day screening period when patients will be tested for eligibility for the
study, a 14-day treatment and blood collection period, and a follow-up evaluation period
beginning 1 day before surgery and continuing to a study termination visit performed at the
patient's discharge from the hospital after surgery. Eligible patients will be randomly
assigned to one of four treatment groups: epoetin alfa 300 units/kilogram (U/kg), epoetin
alfa 600 U/kg, placebo to match the volume of epoetin alfa 300 U/kg, or placebo to match the
volume of epoetin alfa 600 U/kg, given by injection into a vein. Twice as many patients will
receive treatment with epoetin alfa as will receive treatment with placebo. A total of 3
doses of study medication will be administered to each patient, one dose given on each of
Days 1, 4, and 7 of the study. Additionally, from Day 1 to Day 14 of the study, all patients
will receive 200 milligrams of iron and 5 milligrams of a folate supplement daily by mouth to
support red blood cell generation. On Day 1, before the first dose of study drug, one unit of
blood will be collected from each patient and stored for self-donated blood transfusion. An
additional unit of blood will be collected from each patient (before administration of study
drug) and stored for self-donated blood transfusion on each of Days 4, 7, 11, and 14, only if
the patient's hemoglobin level is >11.0 g/dL; if a patient's hemoglobin level is <=11.0 g/dL
on any of these days, no blood will be collected on that day, although study drug will be
given. A maximum of 5 units of blood will be collected from any patient. If sufficient units
for the planned surgery are not collected, preparations will be made for patients to receive
needed units of blood from donors. The study duration is 14 days, ending before surgery.
Safety evaluations will include laboratory tests, vital signs, and reporting of the incidence
of adverse events. Effectiveness will be evaluated by comparing the number of self-donated
units of blood collected within 2 weeks, and the change in hemoglobin level among the
different treatment groups from before the start of the study to the end of the study. The
study hypothesis is that in an abbreviated (2-week) period before surgery, epoetin alfa will
facilitate collection of at least 4 units of self-donated blood in patients who are not
anemic and who are undergoing orthopedic or heart and blood vessel surgery. Epoetin alfa 300
units/kilogram (U/kg), epoetin alfa 600 U/kg, placebo matching the volume of the 300 U/kg
dose, or placebo matching the volume of the 300 U/kg dose, by injection into a vein; given on
each of Days 1, 4, and 7 of the study.