Status:
COMPLETED
A Study of the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Undergoing Orthopedic Surgery and Who Have Low Hematocrit Levels (the Percent of Red Blood Cells in Whole Blood)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Blood Transfusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to determine whether epoetin alfa will facilitate self-donation of blood before surgery in patients who have a...
Detailed Description
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. A large percentage of patients are not able to pre-deposit their own blood for t...
Eligibility Criteria
Inclusion
- Patients scheduled for hip replacement surgery
- having an anticipated requirement of 3 or more units of blood
- having a hematocrit level \<=0.39
- having a hemoglobin level \<= 12.5 grams/deciliter
- having laboratory tests within normal ranges, including stool negative for occult blood
Exclusion
- Patients with a history of any blood disease
- having signs and symptoms of significant disease/dysfunction, or signs and symptoms of significant ongoing blood loss
- having uncontrolled high blood pressure, or a folate, vitamin B12, or iron deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment
- taking medication known to suppress the formation of red blood cells within 1 month before the start of the study
- having a history of seizures, or the presence of active inflammatory disease (e.g., rheumatoid arthritis), however, patients with osteoarthritis may be included in this study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1991
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00270114
End Date
March 1 1991
Last Update
May 18 2011
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