The Effect of PROCRIT (Epoetin Alfa) on Postoperative Vigor and Handgrip Strength (VIGOR Study)

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

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 strength in patients undergoing hip or knee surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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