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

Oral Anticoagulation Clinical Trial

— ECLIPSE-02  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036646
• Other study ID #: BSTE-0125
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: February 8, 2013
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2013
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oral Anticoagulation

Locations

Country	Name	City	State
United States	Fox Valley Cardiology	Aurora	Illinois
United States	Loma Linda VA Hospital	Loma Linda	California
United States	UC Davis Healthcare System	Sacramento	California
United States	San Diego Cardiac Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.		8 weeks	No