Status:
COMPLETED
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
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Anemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
Detailed Description
Major surgical procedures may require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusion...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1991
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00269958
End Date
December 1 1991
Last Update
May 17 2011
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