Study Stopped
The study was terminated due to poor enrollment.
PROCRIT and Short-Term Outcomes in Orthopedic Surgery
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of of PROCRIT� (Epoetin Alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty
1 other identifier
interventional
6
0 countries
N/A
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 unilateral knee surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedJune 10, 2011
March 1, 2010
October 7, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".
Secondary Outcomes (1)
LOS in the inpatient rehabilitation facility; Total FIM score; FIM Physical Sub-score LASA score; FACIT-An score. Safety evaluations include the incidence of adverse events throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
March 1, 2005
Study Completion
October 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-03