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Thromb Haemost 2017; 117(12): 2369-2375
DOI: 10.1160/TH17-04-0280
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH Stuttgart

Diagnostic Accuracy of a Novel Chromogenic Direct Thrombin Inhibitor Assay: Clinical Experiences for Dabigatran Monitoring

Sven Poli
,
Florian Härtig
,
Charlotte Spencer
,
Matthias Ebner
,
Ingvild Birschmann
,
Joachim Kuhn
,
Susanne Faix
,
Ulf Ziemann
,
Hans-Ulrich Häring
,
Rainer Lehmann
,
Andreas Peter
,
Sebastian Hörber
Weitere Informationen

Publikationsverlauf

13. Mai 2017

19. August 2017

Publikationsdatum:
06. Dezember 2017 (online)

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Abstract

Background Direct oral anticoagulants (DOACs) are increasingly replacing vitamin K antagonists (VKA) for clinical indications requiring long-term oral anticoagulation. In contrast to VKA, treatment with DOAC including dabigatran—the only direct thrombin inhibitor amongst them—does not require therapeutic drug monitoring. However, in case of treatment complications (e.g., major haemorrhage) and conditions requiring urgent surgery or thrombolytic therapy, information about actual DOAC plasma levels is needed to guide treatment decisions. Due to short reagent stability, limited accuracy at low dabigatran levels and high heparin sensitivity, the applicability of the widely used Hemoclot thrombin inhibitor (HTI) coagulation assay is limited in the emergency setting.

Methods Dabigatran concentrations of 288 citrated plasma samples taken from 48 dabigatran-treated patients with drug concentrations of up to 300 ng/mL were measured with the chromogenic anti-IIa Biophen direct thrombin inhibitor (BDTI) assay and results compared with HTI using ultra performance liquid chromatography—tandem mass spectrometry as the reference method for measuring dabigatran plasma concentrations.

Results BDTI results showed a very strong correlation with dabigatran concentrations (r = 0.965, p < 0.0001) as well as a low intra- and inter-assay variation of <5%. Compared with HTI, BDTI provides an improved on-board reagent stability of 72 hours, rapid turnaround times comparable to routine coagulation assays, high accuracy at low drug levels and reduced heparin sensitivity.

Conclusion The BDTI is an ideal coagulation assay for the around-the-clock determination of dabigatran plasma levels in clinical routine including emergency situations.

Keywords

oral anticoagulants - clinical trials - dabigatran - NOAC - DOAC

Supplementary Material