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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01036646

Acronym

ECLIPSE-02

Enrollment

183

Registered

2009-12-21

Start date

2009-08-31

Completion date

2010-09-30

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Anticoagulation

Keywords

Patients on stable OAT therapy for at least 3 months.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results