A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00269971
First received: December 22, 2005
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.


Condition Intervention Phase
Anemia
Blood Transfusion
Orthopedic Surgery
Drug: epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Parallel Group Placebo-Controlled Study to Determine an Effective Dose Regimen for EPREX� (Epoetin Alfa) Sterile Solution to Reduce Transfusion Requirements in Patients Undergoing Major Elective Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:
  • Transfusion requirements at the time of surgery; hemoglobin and hematocrit levels, reticulocyte count, and iron stores prior to surgery; time to hospital discharge after surgery, and the patient's quality of life after surgery.

Secondary Outcome Measures:
  • Deep-vein blood clots; other adverse events, changes in clinical laboratory tests, vital sign measurements, and physical examination findings.

Enrollment: 214
Study Start Date: May 1996
Study Completion Date: April 1999
Detailed Description:

Major surgical procedures may require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, multicenter study in patients scheduled for first time hip replacement surgery. The study compares the effectiveness of 2 different doses of epoetin alfa (20,000 units or 40,000 units per week) for reducing the need for blood transfusions during the surgery. Eligible patients will be randomly assigned to one of three treatment groups: epoetin alfa 20,000 units per week, epoetin alfa 40,000 units per week, or placebo. Patients will be treated with study medication once a week for 4 weeks before their scheduled surgery. Effectiveness will be determined by the number of transfusions required during surgery. Other factors that determine effectiveness will be: the level of hemoglobin (the oxygen-carrying component of red blood cells) and the percentage of red blood cells in the patient's blood (hematocrit) prior to surgery; the number of developing red blood cells (reticulocytes); the iron stores in the patient's blood prior to surgery; the patient's quality of life after the surgery; and the time that elapses after surgery before the patient is discharged from the hospital. Safety evaluations will include the incidence of blood clots in the deep veins, the incidence and severity of other adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa before hip replacement surgery will require fewer blood transfusions during the surgery compared with patients treated with placebo, and that the lower epoetin alfa dose (20,000 units per week) is as effective as the higher epoetin alfa dose (40,000 units per week). Patients will receive 20,000 units or 40,000 units of epoetin alfa injected under the skin once weekly for 4 weeks, or a matching placebo injection containing human serum albumin.

  Eligibility

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

Inclusion Criteria:

  • Patients scheduled for first-time hip replacement surgery
  • having no major medical conditions
  • having a hemoglobin level of 98 - 137 grams per liter
  • having adequate iron stores
  • not participating in a self-donated blood program

Exclusion Criteria:

  • Patients with a history of rheumatoid arthritis, blood disorders, recent bleeding episodes or an iron deficiency
  • or having a history of seizures or uncontrolled high blood pressure (diastolic blood pressure > 100 mmHg)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269971

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00269971     History of Changes
Other Study ID Numbers: CR005908
Study First Received: December 22, 2005
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:
hip replacement
hip replacement surgery
surgery
anemia
transfusions
blood
blood transfusions

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014