A Study to Evaluate the Safety of Epoetin Alfa and Its Effectiveness in Facilitating the Presurgical Collection of Blood From Anemic Patients for Possible Self-transfusion During and After Scheduled Joint Surgery.

• Status: Completed
• Trial end date: 1991-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in facilitating the presurgical collection of blood from anemic patients for possible self-transfusion during and after scheduled joint surgery and its effectiveness in reducing surgery-related transfusion requirements. 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 involving the joints, 25 to 35 days after starting epoetin alfa therapy

• having a hematocrit (percentage of red cells in the blood) of <=39%

• in good general health.

Exclusion Criteria:

• Patients with a history of any primary blood disease

• having a history of artery blockage in the heart, body or brain, a history of seizures, uncontrolled high blood pressure, or active inflammatory disease, (except osteoarthritis or rheumatoid arthritis)

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

• using of any cell toxic drug, drugs that suppress the immune system, or drugs known to influence red blood cell production (such as chemotherapy for cancer) within 1 month of therapy

• having a folate or vitamin B12 deficiency, iron-deficiency anemia, or a disease that destroys blood cells.