Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01037270

Acronym

ECLIPSE-01

Enrollment

271

Registered

2009-12-22

Start date

2009-08-31

Completion date

2010-06-30

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

Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Keywords

Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.

Brief summary

This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults (18 years of age or older); * Willing and able to provide written informed consent and comply with study procedures; * Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.

Exclusion criteria

* Hematocrit less than 25 or greater than 55%; * Lupus or antiphospholipid syndrome (APS) * Vulnerable populations deemed inappropriate for study by the site's principal investigator. * Already participated in this study.

Design outcomes

Primary

Measure	Time frame
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.	3-6 months

Countries

United States

Outcome results