Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Facilitating the Presurgical Collection of Blood to be Used for Self-donation During Surgery on the Spine, Hip, or Knee.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Blood Transfusions, Autologous
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating presurgical collecti...
Detailed Description
Major surgical procedures may require transfusion of several units of blood. Blood transfusions from other people may be associated with transfusion reactions that cause fever or with viral infections...
Eligibility Criteria
Inclusion
- Patients scheduled for surgery on the knee, hip, or spine between 25 and 35 days after starting epoetin alfa therapy
- having a hematocrit (percentage of red cells in the blood) of \>39 percent and \<=50 percent
- in good general health
Exclusion
- Patients having a history of any primary blood disease
- having a history of artery blockage in the heart, body or brain, or a history of seizures
- having uncontrolled high blood pressure, a folate deficiency, vitamin B12 deficiency or iron deficiency anemia, active inflammatory disease (except osteoarthritis or rheumatoid arthritis) or a disease that destroys blood cells
- losing blood from the stomach, intestines or elsewhere in the body
- having received therapy with any drug known to affect red blood cell formation (such as chemotherapy for cancer)
Key Trial Info
Start Date :
September 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1991
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00270140
Start Date
September 1 1989
End Date
August 1 1991
Last Update
May 18 2011
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