Status:
COMPLETED
The Effect of PROCRIT (Epoetin Alfa) on Postoperative Vigor and Handgrip Strength (VIGOR Study)
Lead Sponsor:
Ortho Biotech, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to compare the effect of epoetin alfa to preoperative autologous blood donation (PAD) on postoperative vigor (a measure of functional ability and well-being) and handgrip...
Detailed Description
Total joint arthroplasty (including hip and knee surgery) often leads to significant blood loss and may result in the need for blood transfusion. To prepare for this possibility, patients frequently d...
Eligibility Criteria
Inclusion
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee
- pretreatment hemoglobin level of 11 to 14 g/dL
- enrollment 21-60 days in advance of surgery
Exclusion
- No uncontrolled hypertension
- No seizure disorder
- No history of deep vein thrombosis
- No significant gastrointestinal bleeding in previous 6 months
- No clinically significant hematologic, cardiovascular, neurological, pulmonary, endocrine, gastrointestinal, or genitourinary disease
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT00401869
Start Date
February 1 1999
End Date
December 1 2001
Last Update
April 6 2010
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.