PROCRIT and Short-Term Outcomes in Orthopedic Surgery - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00236405

Purpose

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.

Condition	Intervention	Phase
Surgery, Arthroscopy Anemia	Drug: epoetin alfa	Phase II

MedlinePlus related topics: Anemia Rehabilitation Surgery

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	72
Study Start Date:	March 2005
Study Completion Date:	October 2005

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 subjects undergoing primary unilateral knee arthroplasty. Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay. The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation.

40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236405

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Procrit (Epoetin alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR003193
Study First Received:	October 7, 2005
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00236405 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

erythropoetin
Anemia
quality-of-life outcomes

Study placed in the following topic categories:

Epoetin Alfa
Hematinics
Hematologic Diseases
Anemia
Quality of Life

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009