Status:
COMPLETED
A Study to Evaluate the Safety of Epoetin Alfa and Its Effectiveness in Facilitating the Presurgical Collection of Blood From Anemic Patients for Possible Self-transfusion During and After Scheduled Joint Surgery.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in facilitating the presurgical collection of blood from anemic patients for possible self-transfusion during ...
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 infections such as he...
Eligibility Criteria
Inclusion
- Patients scheduled for surgery involving the joints, 25 to 35 days after starting epoetin alfa therapy
- having a hematocrit (percentage of red cells in the blood) of \<=39%
- in good general health.
Exclusion
- Patients with a history of any primary blood disease
- having a history of artery blockage in the heart, body or brain, a history of seizures, uncontrolled high blood pressure, or active inflammatory disease, (except osteoarthritis or rheumatoid arthritis)
- losing blood internally from the stomach or intestines or elsewhere in the body
- using of any cell toxic drug, drugs that suppress the immune system, or drugs known to influence red blood cell production (such as chemotherapy for cancer) within 1 month of therapy
- having a folate or vitamin B12 deficiency, iron-deficiency anemia, or a disease that destroys blood cells.
Key Trial Info
Start Date :
May 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1991
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00270062
Start Date
May 1 1989
End Date
July 1 1991
Last Update
May 18 2011
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