- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270036
A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery.
Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing major orthopedic surgery frequently 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, placebo-controlled, parallel group, multicenter study.
The study compares the effectiveness of epoetin alfa in reducing the need for blood transfusions in patients who are expected to require at least 2 units of blood following major orthopedic surgery.
Eligible patients will be randomly assigned to receive either epoetin alfa (100 or 300 U/kg, depending upon their body weight) or a matching placebo, by injection beneath the skin starting 10 days before scheduled surgery, on the day of surgery (after surgery), and for 4 days after surgery.
Additionally, all patients will start taking an oral iron supplement at least 10 days before their scheduled surgery.
Effectiveness will be determined by the number of transfusions required following surgery, and on changes in hematocrit (iron-containing pigment in red blood cells), hemoglobin (oxygen-carrying component of red blood cells), and reticulocyte (immature red blood cells) levels from the start of the study to the end of the study.
Safety evaluations will include the incidence and severity of 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 will require fewer blood transfusions after surgery than patients treated with placebo.
Epoetin alfa (300 U/kg or 100 U/kg), or matching placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- having no significantly abnormal blood or urine test results
- having a hematocrit <= 45%
Exclusion Criteria:
- Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- having signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- received a blood transfusion within 1 month before the start of the study
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 following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events; Changes in clinical laboratory test results, vital signs, and physical examination findings
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
April 1, 1991
Study Completion (Actual)
October 1, 1991
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)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005902
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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