A Study to Determine Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients During the Period of Time Around Major Orthopedic Surgery.

• Status: Completed
• Trial end date: 1994-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether epoetin alfa will reduce the need for blood transfusions during the period of time around major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients scheduled for major orthopedic surgery involving the hip or knee, who are expected to require transfusion of at least 2 units of red blood cells

• who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery

• in good general health

• having no significantly abnormal laboratory blood, urine, or stool tests

Exclusion Criteria:

• Patients having any blood disease, hepatitis B, signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment, or who have tested positive for HIV (human immunodeficiency virus)

• who are unable to use Coumadin (a medication to prevent blood clots in veins)

• having a recent history of stomach or intestinal bleeding, bleeding inside the skull, or the signs and symptoms of significant and ongoing blood loss

• having a seizure disorder, uncontrolled high blood pressure, the presence of active inflammatory disease (i.e., rheumatoid arthritis, however, patients with osteoarthritis may be included in this study) or the signs and symptoms of a significant disease and/or dysfunction

• received a blood transfusion within 1 month before the start of the study, received medication known to suppress formation of red blood cells within 1 month before the start of the study, or having infections or cancers that may make it difficult to respond to the study drug