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)

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: Oral Anticoagulation

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• United States
  • 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

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

How is the study designed?

Number of groups / cohorts

2

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.	8 weeks

Collaborators and Investigators

• Sponsor: Biosite

Study record dates

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

• Keywords: Patients on stable OAT therapy for at least 3 months.
• Other Study ID Numbers: BSTE-0125