Status:
COMPLETED
A Study to Determine Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients During the Period of Time Around Major Orthopedic Surgery.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Blood Transfusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether epoetin alfa will reduce the need for blood transfusions during the period of time around major orthopedic ...
Detailed Description
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. These transfusions can result in adverse reactions, such as a blood clot in a de...
Eligibility Criteria
Inclusion
- Patients scheduled for major orthopedic surgery involving the hip or knee, 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
- in good general health
- having no significantly abnormal laboratory blood, urine, or stool tests
Exclusion
- Patients having any blood disease, hepatitis B, signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment, or who have tested positive for HIV (human immunodeficiency virus)
- who are unable to use Coumadin (a medication to prevent blood clots in veins)
- having a recent history of stomach or intestinal bleeding, bleeding inside the skull, or the signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, the presence of active inflammatory disease (i.e., rheumatoid arthritis, however, patients with osteoarthritis may be included in this study) or the signs and symptoms of a significant disease and/or dysfunction
- received a blood transfusion within 1 month before the start of the study, received medication known to suppress formation of red blood cells within 1 month before the start of the study, or having infections or cancers that may make it difficult to respond to the study drug
Key Trial Info
Start Date :
April 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1994
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00270088
Start Date
April 1 1993
End Date
August 1 1994
Last Update
May 18 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.