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, Sven Poli

Journal: Critical care (London, England) 2018;21(1):32

PMID: 28196509

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Abstract

BACKGROUND

Point-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.

METHODS

We 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.

RESULTS

Four 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.

CONCLUSIONS

Hemochron® 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 REGISTRATION

Unique identifier, NCT02371070 . Retrospectively registered on 18 February 2015.

Address: Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.; Department of Internal Medicine and Cardiology, Charité University Medicine Berlin - Campus Virchow Klinikum, Berlin, Germany.; Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany.; Department of Internal Medicine, Division of Endocrinology, Diabetology, Angiology, Nephrology and Clinical Chemistry, University of Tübingen, Tübingen, Germany.; Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.; German Center for Diabetes Research (DZD), Tübingen, Germany.; Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.; Department of Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany.; Department of Cardiology and Cardiovascular Medicine, University of Tübingen, Tübingen, Germany.; Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany. [email protected].

DOI: 10.1186/s13054-017-1619-z

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MeSH Terms: Anticoagulants, Blood Coagulation Tests, Dabigatran, Factor Xa Inhibitors, Humans, Partial Thromboplastin Time, Point-of-Care Systems, Prospective Studies, Prothrombin Time, Pyrazoles, Pyridones, Rivaroxaban, Thrombin Time