A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.

• Status: Completed
• Trial end date: 1991-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 2
• 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 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

• having no significantly abnormal blood or urine test results

• having a hematocrit <= 45%

Exclusion Criteria:

• Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction

• having signs and symptoms of significant and ongoing blood loss

• having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug

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

• received a blood transfusion within 1 month before the start of the study