This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.
Study Type
OBSERVATIONAL
Enrollment
150
Loma Linda VA
Loma Linda, California, United States
University of Colorado-Denver
Aurora, Colorado, United States
Henry Ford Hospital
Detroit, Michigan, United States
Emergency Medicine Research Group
Lansing, Michigan, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
International Heart Institute of Montana
Missoula, Montana, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York Methodist Hospital
Brooklyn, New York, United States
John T Mather Memorial Hospital
Port Jefferson, New York, United States
Northwest Heart Center
Tomball, Texas, United States
...and 2 more locations
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