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

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.

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Key information

Conditions

Pulmonary Embolism Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Heart Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda VA Hospital, Loma Linda, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.

Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Abbott RDx Cardiometabolic

Other

Registry information

Acronym: ECLIPSE-01

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 22, 2009
Registry last updated: Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed