A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo to Reduce the Need for Blood Transfusions and Reduce the Occurrence of Severe Anemia During the Time Period Surrounding Total Hip Replacement Surgery

• Status: Completed
• Trial end date: 1991-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of two different dosing schedules of epoetin alfa versus placebo for decreasing the need for blood transfusions and preventing the occurrence of severe anemia during the period of time around total hip replacement surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients scheduled for elective, first-time hip-replacement surgery or a second hip-replacement surgery (with surgery taking place within 48 hours of the scheduled time)

• having a baseline hemoglobin between 110 and 160 grams per liter

• with no significantly abnormal values for laboratory tests that would indicate an impaired ability to respond to epoetin alfa.

Exclusion Criteria:

• Patients with a primary hematologic disease

• having any clinically significant disease/dysfunction of the neurologic, pulmonary, endocrine, cardiovascular, gastrointestinal, or genitourinary systems

• who have had a seizure disorder in the past 5 years, or who are currently on anticonvulsant therapy

• having uncontrolled high blood pressure

• currently experiencing an ongoing blood loss