A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.

• Status: Completed
• Trial end date: 1988-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major 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

• expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood

• in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces

• who are not severely obese

Exclusion Criteria:

• Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells >50% of the blood

• having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells

• having a history of seizure or uncontrolled hypertension

• having clinically significant bleeding in the stomach/intestines or elsewhere

• received a blood transfusion or received androgen therapy within 1 month prior to the start of study