Status:
TERMINATED
PROCRIT and Short-Term Outcomes in Orthopedic Surgery
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Surgery, Arthroscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 unil...
Detailed Description
The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00236405
Start Date
March 1 2005
End Date
October 1 2005
Last Update
June 10 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.