A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Facilitating the Presurgical Collection of Blood to be Used for Self-donation During Surgery on the Spine, Hip, or Knee.

• Status: Completed
• Trial end date: 1991-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating presurgical collection of blood for self-donation during surgery of the knee, hip or spine. 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 surgery on the knee, hip, or spine between 25 and 35 days after starting epoetin alfa therapy

• having a hematocrit (percentage of red cells in the blood) of >39 percent and <=50 percent

• in good general health

Exclusion Criteria:

• Patients having a history of any primary blood disease

• having a history of artery blockage in the heart, body or brain, or a history of seizures

• having uncontrolled high blood pressure, a folate deficiency, vitamin B12 deficiency or iron deficiency anemia, active inflammatory disease (except osteoarthritis or rheumatoid arthritis) or a disease that destroys blood cells

• losing blood from the stomach, intestines or elsewhere in the body

• having received therapy with any drug known to affect red blood cell formation (such as chemotherapy for cancer)