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

Completed

Conditions studied: Pulmonary Embolism, Atrial Fibrillation, Deep Vein Thrombosis

In brief

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.

Key facts

Study ID

NCT01037270

Run by

Abbott RDx Cardiometabolic

People needed

271

Starts

2009-08-01

Expected to finish

2010-06-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Loma Linda VA Hospital — Loma Linda, California, United States
• UC Davis Healthcare System — Sacramento, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• Fox Valley Cardiology — Aurora, Illinois, United States

Full record on ClinicalTrials.gov

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