- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037270
Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity (ECLIPSE-01)
February 8, 2013 updated by: Biosite
This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT).
These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
271
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Loma Linda, California, United States, 92357
- Loma Linda VA Hospital
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Sacramento, California, United States, 95817
- UC Davis Healthcare System
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San Diego, California, United States, 92123
- San Diego Cardiac Center
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Illinois
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Aurora, Illinois, United States, 60504
- Fox Valley Cardiology
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-
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
Sampling Method
Non-Probability Sample
Study Population
Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
Description
Inclusion Criteria:
- Adults (18 years of age or older);
- Willing and able to provide written informed consent and comply with study procedures;
- Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.
Exclusion Criteria:
- Hematocrit less than 25 or greater than 55%;
- Lupus or antiphospholipid syndrome (APS)
- Vulnerable populations deemed inappropriate for study by the site's principal investigator.
- Already participated in this 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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.
Time Frame: 3-6 months
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 19, 2009
First Posted (Estimate)
December 22, 2009
Study Record Updates
Last Update Posted (Estimate)
February 11, 2013
Last Update Submitted That Met QC Criteria
February 8, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSTE-0124
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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