Status:
COMPLETED
A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Blood Transfusion
Orthopedic Procedures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoe...
Detailed Description
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the ...
Eligibility Criteria
Inclusion
- Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- having no significantly abnormal blood or urine test results
- having a hematocrit \<= 45%
Exclusion
- Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- having signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- received a blood transfusion within 1 month before the start of the study
Key Trial Info
Start Date :
April 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 1991
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00270036
Start Date
April 1 1991
End Date
October 1 1991
Last Update
May 18 2011
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