Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)



Status:Archived
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2009
End Date:May 2010

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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.



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Lansing, Michigan 48910
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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Loma Linda, California 92357
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Missoula, MT
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Port Jefferson, New York 11777
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tomball, Texas 77375
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Tomball, TX
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