- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270179
A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Placebo-Controlled Study to Determine Whether R-huEPO Can Facilitate Presurgical Autologous Blood Donation and to Determine Its Safety for This Purpose
The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major surgery.
Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Study Overview
Detailed Description
Major surgical procedures may require several units of blood.
Blood transfusions from other people may be associated with transfusion reactions that cause fever or uncommonly, blood-borne infections.
However, self-blood collections may cause anemia in a patient who will be undergoing surgery a few weeks later.
Previous research with epoetin alfa suggests that it increases the rate of red blood cell production and has a beneficial effect on anemia.
This randomized, double-blind, placebo-controlled 21-day study is designed to determine whether intravenous epoetin alfa will stimulate a patient's bone marrow to produce red blood cells and therefore increase a patient's ability to self-donate blood prior to major surgery for joint disease.
Patients will be randomly assigned to receive either epoetin alfa 600 units per kilogram of body weight or a matching volume of placebo injected into a vein on the first study day and every 3 to 4 days thereafter for 21 days, for a total of 6 doses.
The primary measures of effectiveness will be determined by the number of units of blood that can be obtained from patients during the study, the change in hemoglobin and hematocrit from pre-study to post-study, and the number of transfusions required around the time of surgery.
Safety will be evaluated based on laboratory tests, vital signs, and the incidence and severity of any adverse or unusual experiences associated with drug administration.
The study hypothesis is that patients treated with epoetin alfa will be able to donate more units of blood for their own surgery while receiving epoetin alfa than patients receiving placebo.
Epoetin alfa 600 units per kilogram or an equal volume of placebo injected into a vein on the first day of the study, and every 3 to 4 days thereafter until day 21, for a total of 6 doses.
Study Type
Interventional
Enrollment (Actual)
17
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for major orthopedic surgery
- expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood
- in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces
- who are not severely obese
Exclusion Criteria:
- Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells >50% of the blood
- having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells
- having a history of seizure or uncontrolled hypertension
- having clinically significant bleeding in the stomach/intestines or elsewhere
- received a blood transfusion or received androgen therapy within 1 month prior to the start of 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 |
---|
Units of blood that can be obtained per patient; Change from pre-study to post-study in hemoglobin and hematocrit; Transfusions required around the time of surgery
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety (clinical laboratory tests, vital signs, incidence and severity of any adverse or unusual experiences associated with drug administration)
|
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
December 7, 2022
Primary Completion
December 7, 2022
Study Completion (Actual)
May 1, 1988
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
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005926
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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