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CC BY-NC-ND 4.0 · Thromb Haemost 2021; 121(06): 782-791
DOI: 10.1055/s-0040-1721775
New Technologies, Diagnostic Tools and Drugs

Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran

Florian Härtig
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
,
Ingvild Birschmann
3   Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany
,
Andreas Peter
4   German Centre for Diabetes Research (DZD), Neuherberg, Germany
5   Institute for Diabetes Research and Metabolic Diseases, Helmholtz Centre Munich, University of Tübingen, Tübingen, Germany
6   Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany
,
Matthias Ebner 
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
7   Department of Internal Medicine and Cardiology, Campus Virchow Hospital, Charité, Berlin, Germany
,
Charlotte Spencer
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
,
Michael Gramlich
8   Department of Cardiology, University Hospital Tübingen, Germany
,
Hardy Richter
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
,
Joachim Kuhn
3   Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany
,
Rainer Lehmann
4   German Centre for Diabetes Research (DZD), Neuherberg, Germany
5   Institute for Diabetes Research and Metabolic Diseases, Helmholtz Centre Munich, University of Tübingen, Tübingen, Germany
6   Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany
,
Gunnar Blumenstock
9   Department of Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany
,
Christine S. Zuern
8   Department of Cardiology, University Hospital Tübingen, Germany
10   Department of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, University of Basel, Basel, Switzerland
,
Ulf Ziemann
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
,
Sven Poli
1   Department of Neurology & Stroke, Eberhard Karls University of Tübingen, Tübingen, Germany
2   Hertie Institute for Clinical Brain Research, Eberhard Karls University of Tübingen, Tübingen, Germany
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Abstract

Background and Purpose Accurate and rapid assessment of coagulation status is necessary to guide thrombolysis or reversal of anticoagulation in stroke patients, but commercially available point-of-care (POC) assays are not suited for coagulation testing in patients treated with direct oral anticoagulants (DOACs). We aimed to evaluate the direct thrombin monitoring (DTM) test card by Helena Laboratories (Texas, United States) for anti-IIa-specific POC coagulation testing, hypothesizing that its POC-ecarin clotting time (POC-ECT) accurately reflects dabigatran plasma concentrations.

Methods A prospective single-center diagnostic study (ClinicalTrials.gov-identifier: NCT02825394) was conducted enrolling patients receiving a first dose of dabigatran and patients already on dabigatran treatment. Blood samples were collected before drug intake and 0.5, 1, 2, 8, and 12 hours after intake. POC-ECT was performed using whole blood (WB), citrated blood (CB), and citrated plasma (CP). Dabigatran plasma concentrations were determined by mass spectrometry.

Results In total, 240 blood samples from 40 patients contained 0 to 275 ng/mL of dabigatran. POC-ECT with WB/CB/CP ranged from 20 to 186/184/316 seconds. Pearson's correlation coefficient showed a strong correlation between dabigatran concentrations and POC-ECT with WB/CB/CP (R2  = 0.78/0.90/0.92). Dabigatran concentrations >30 and >50 ng/mL (thresholds for thrombolysis, surgery, and reversal therapy according to clinical guidelines) were detected by POC-ECT with WB/CB/CP (>36/35/45 and >43/45/59 seconds) with 95/97/97 and 96/98/97% sensitivity, and 81/87/94 and 74/60/91% specificity.

Conclusion This first study evaluating DOAC-specific POC coagulation testing revealed an excellent correlation of POC-ECT with actual dabigatran concentrations. Detecting clinically relevant dabigatran levels with high sensitivity/specificity, the DTM assay represents a suitable diagnostic tool in acute stroke, hemorrhage, and urgent surgery.

Keywords

dabigatran - point-of-care testing - ecarin clotting time - thrombolysis - anticoagulation

Supplementary Material



Publication History

Received: 29 September 2020

Accepted: 08 November 2020

Article published online:
14 January 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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