- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269971
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.
September 19, 2016 updated by: Janssen-Ortho Inc., Canada
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Deep-vein blood clots; other adverse events, changes in clinical laboratory tests, vital sign measurements, and physical examination findings.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 1996
Primary Completion
December 7, 2022
Study Completion (Actual)
April 1, 1999
Study Registration Dates
First Submitted
December 22, 2005
First Submitted That Met QC Criteria
December 22, 2005
First Posted (Estimate)
December 26, 2005
Study Record Updates
Last Update Posted (Estimate)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005908
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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