• Crit Care · Feb 2017

    Clinical Trial Observational Study

    Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants.

    • Matthias Ebner, Ingvild Birschmann, Andreas Peter, Charlotte Spencer, Florian Härtig, Joachim Kuhn, Gunnar Blumenstock, Christine S Zuern, Ulf Ziemann, and Sven Poli.
    • Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.
    • Crit Care. 2017 Feb 15; 21 (1): 32.

    BackgroundPoint-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. Specific POCT for direct oral anticoagulants (DOAC) is not available, but the effects of DOAC on established POCT have been described. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients.MethodsWe enrolled 68 patients receiving apixaban, rivaroxaban, or dabigatran and obtained blood samples at six pre-specified time points. Coagulation testing was performed using prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and activated clotting time (ACT+ and ACT-low range) POCT cards. For comparison, laboratory-based assays of diluted thrombin time (Hemoclot) and anti-Xa activity were conducted. DOAC concentrations were determined by liquid chromatography-tandem mass spectrometry.ResultsFour hundred and three samples were collected. POCT results of PT/INR and ACT+ correlated with both rivaroxaban and dabigatran concentrations. Insufficient correlation was found for apixaban. Rivaroxaban concentrations at <30 and <100 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.0 and ≤1.1 and ACT+ POCT ≤120 and ≤130 s. Dabigatran concentrations at <30 and <50 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.1 and ≤1.2 and ACT+ POCT ≤100 s.ConclusionsHemochron® Signature POCT can be a fast and reliable alternative for guiding emergency treatment during rivaroxaban and dabigatran therapy. It allows the rapid identification of a relevant fraction of patients that can be treated immediately without the need to await the results of much slower laboratory-based coagulation tests.Trial RegistrationUnique identifier, NCT02371070 . Retrospectively registered on 18 February 2015.

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