PROCRIT and Short-Term Outcomes in Orthopedic Surgery

• Status: Terminated
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of perioperative administration of PROCRIT to that of autologous blood donation on post-operative rehabilitation outcomes in patients undergoing unilateral knee surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility

• Hemoglobin >11 to <13 g/dL at screening and preoperative day -21

• Age 18 years or older

• Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable

• Preoperative lead time of at least 21 days

Exclusion Criteria:

• Medical conditions including: Known iron deficiency (defined as serum ferritin <50 mg/l)

• chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures

• Expected to need another lower extremity major joint replacement within six months

• Undergoing cancer chemotherapy

• History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis