A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.

• Status: Withdrawn
• Trial end date: 1999-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients scheduled for first-time hip replacement surgery

• having no major medical conditions

• having a hemoglobin level of 98 - 137 grams per liter

• having adequate iron stores

• not participating in a self-donated blood program

Exclusion Criteria:

• Patients with a history of rheumatoid arthritis, blood disorders, recent bleeding episodes or an iron deficiency

• or having a history of seizures or uncontrolled high blood pressure (diastolic blood pressure > 100 mmHg)