Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major ...
Detailed Description
Major surgical procedures may require several units of blood. Blood transfusions from other people may be associated with transfusion reactions that cause fever or uncommonly, blood-borne infections. ...
Eligibility Criteria
Inclusion
- Patients scheduled for major orthopedic surgery
- expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood
- in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces
- who are not severely obese
Exclusion
- Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells \>50% of the blood
- having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells
- having a history of seizure or uncontrolled hypertension
- having clinically significant bleeding in the stomach/intestines or elsewhere
- received a blood transfusion or received androgen therapy within 1 month prior to the start of study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1988
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00270179
End Date
May 1 1988
Last Update
May 18 2011
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