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Anticoagulant Therapy

FDA Public Workshop on DOACs

The US Food and Drug Administration has released the full transcript and video recordings of their October 26, 2015 all day public workshop, “In Vitro Diagnostic Testing for Direct Oral Anticoagulants.” The workshop features Frederick Korley, Adam Cuker, Dorothy Adcock-Funk, Robert Gosselin, Stephan Moll, and several FDA representatives. Here is the transcript: /sites/default/files/doac_testing_fda_transcript_10-26-15.pdf  
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Switching From Rivaroxaban to Heparin

We’ve widely acknowledged that the anti-Xa assay, currently employed to monitor heparin therapy, may be readily adapted to measuring direct oral anti-Xa antthrombotics, and at least three hemostasis diagnostics manufacturers have developed and validated rivaroxaban and apixaban calibrators and controls for this purpose. These await US FDA clearance. Meanwhile, we estimate oral anti-Xa antithrombotic efficacy […]
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Platelet Count and POC PT/INR

A participant asks if point of care PT/INR results are affected by the platelet count. George responds that POC PT/INR instrument package inserts list no effects related to thrombocytopenia or thrombocytosis. Documented interferences include specimen management errors that result in partial preanalytical clotting, foaming, or hemolysis; hematocrit below 20% or above 55%, presence of coagulopathies […]
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