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Poli, S.* ; Härtig, F.* ; Spencer, C.* ; Ebner, M.* ; Birschmann, I.* ; Kuhn, J.* ; Faix, S.* ; Ziemann, U.* ; Häring, H.-U. ; Lehmann, R. ; Peter, A. ; Hörber, S.*

Diagnostic accuracy of a novel chromogenic direct thrombin inhibitor assay: Clinical experiences for dabigatran monitoring.

Thromb. Haemost. 117, 2369-2375 (2017)
DOI PMC
Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.
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.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Oral Anticoagulants ; Clinical Trials ; Dabigatran ; Noac ; Doac; Nonvalvular Atrial-fibrillation; Antagonist Oral Anticoagulants; Dresden Noac Registry; Daily-care Patients; Venous Thromboembolism; Plasma-concentrations; Emergency Management; Coagulation Assays; Practical Guide; Rivaroxaban
Sprache englisch
Veröffentlichungsjahr 2017
HGF-Berichtsjahr 2017
ISSN (print) / ISBN 0340-6245
Zeitschrift Thrombosis and Haemostasis
Quellenangaben Band: 117, Heft: 12, Seiten: 2369-2375 Artikelnummer: , Supplement: ,
Verlag Schattauer
Verlagsort Stuttgart
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Diabetes Research and Metabolic Diseases (IDM)
POF Topic(s) 90000 - German Center for Diabetes Research
Forschungsfeld(er) Helmholtz Diabetes Center
PSP-Element(e) G-502400-001
G-502400-002
DOI 10.1160/TH17-04-0280
WOS ID WOS:000423998200016
PubMed ID 29212124
Erfassungsdatum 2018-01-29
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