A Study of the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Undergoing Orthopedic Surgery and Who Have Low Hematocrit Levels (the Percent of Red Blood Cells in Whole Blood)

• Status: Completed
• Trial end date: 1991-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to determine whether epoetin alfa will facilitate self-donation of blood before surgery in patients who have anemia, (as indicated by low hematocrit levels, the percent of red blood cells in whole blood) and who will be undergoing orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 2/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 hip replacement surgery

• having an anticipated requirement of 3 or more units of blood

• having a hematocrit level <=0.39

• having a hemoglobin level <= 12.5 grams/deciliter

• having laboratory tests within normal ranges, including stool negative for occult blood

Exclusion Criteria:

• Patients with a history of any blood disease

• having signs and symptoms of significant disease/dysfunction, or signs and symptoms of significant ongoing blood loss

• having uncontrolled high blood pressure, or a folate, vitamin B12, or iron deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment

• taking medication known to suppress the formation of red blood cells within 1 month before the start of the study

• having a history of seizures, or the presence of active inflammatory disease (e.g., rheumatoid arthritis), however, patients with osteoarthritis may be included in this study