- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01036646
User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity (ECLIPSE-02)
February 8, 2013 updated by: Biosite
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood.
Patients will be trained by their healthcare provider using the instructions for use and product labeling provided.
The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
183
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
-
Loma Linda, California, United States, 92357
- Loma Linda VA Hospital
-
Sacramento, California, United States, 95817
- UC Davis Healthcare System
-
San Diego, California, United States, 92123
- San Diego Cardiac Center
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Fox Valley Cardiology
-
-
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
Patients will be recruited from their primary care clinic.
Description
Inclusion Criteria:
- Adults (18 years of age or older);
- Ability to read and speak English;
- Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
- Target INR interval between 2.0 and 4.5
- Willing and able to provide written informed consent and comply with study procedures;
Exclusion Criteria:
- Hematocrit less than 25 or greater than 55%
- Lupus or antiphospholipid syndrome (APS)
- Already participated in this study
- A current INRatio PT Monitoring System User / Patient Self Tester
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
Cohorts and Interventions
Group / Cohort |
---|
BSTE-0125-Original Protocol
|
BSTE-0125.a-Amended Protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.
Time Frame: 8 weeks
|
8 weeks
|
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)
June 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimate)
December 21, 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
Other Study ID Numbers
- BSTE-0125
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.
Clinical Trials on Oral Anticoagulation
-
University Hospital, MontpellierCompletedUnder Oral Anticoagulation PatientsFrance
-
IRCCS Policlinico S. DonatoNot yet recruitingAdults Undergoing Oral Anticoagulation TherapyItaly
-
University Hospital TuebingenHeart and Diabetes Center North Rhine-WestphaliaCompletedAnticoagulation With Direct Oral Anticoagulants
-
University Hospital TuebingenHeart and Diabetes Center North Rhine-WestphaliaCompletedAnticoagulation With Direct Oral Anticoagulants
-
Fundació Institut de Recerca de l'Hospital de la...CompletedSelf Management of Oral Anticoagulation With VKA TherapySpain
-
University Hospital TuebingenHeart and Diabetes Center North Rhine-WestphaliaRecruitingAnticoagulation With Direct Oral AnticoagulantsGermany
-
Cairo UniversityRecruitingMaternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve ProsthesisEgypt
-
Brigham and Women's HospitalCSL BehringRecruitingAnticoagulation | Anticoagulation ReversalUnited States
-
University of TurkuCompletedAtrial Fibrillation | Percutaneous Coronary Intervention | Oral AnticoagulationFinland
-
William S. Middleton Memorial Veterans HospitalUniversity of Wisconsin, MadisonCompleted