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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)

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ClinicalTrials.gov Identifier: NCT01036646
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease
Oral Anticoagulation

Study Type : Observational
Actual Enrollment : 183 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2009
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

BSTE-0125-Original Protocol
BSTE-0125.a-Amended Protocol

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Plasma specimens retained for reference method comparison.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from their primary care clinic.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036646

United States, California
Loma Linda VA Hospital
Loma Linda, California, United States, 92357
UC Davis Healthcare System
Sacramento, California, United States, 95817
San Diego Cardiac Center
San Diego, California, United States, 92123
United States, Illinois
Fox Valley Cardiology
Aurora, Illinois, United States, 60504
Sponsors and Collaborators

Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01036646     History of Changes
Other Study ID Numbers: BSTE-0125
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Biosite:
Patients on stable OAT therapy for at least 3 months.