PROCRIT and Short-Term Outcomes in Orthopedic Surgery

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 2

Conditions

Anemia

Surgery, Arthroscopy

Treatments

Drug: epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236405

CR003193

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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