Open Access Green as soon as Postprint is submitted to ZB.
Diagnostic accuracy of a novel chromogenic direct thrombin inhibitor assay: Clinical experiences for dabigatran monitoring.
Thromb. Haemost. 117, 2369-2375 (2017)
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.
Impact Factor
Scopus SNIP
Web of Science
Times Cited
Times Cited
Scopus
Cited By
Cited By
Altmetric
5.627
0.000
9
8
Annotations
Special Publikation
Hide on homepage
Publication type
Article: Journal article
Document type
Scientific Article
Keywords
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
Language
english
Publication Year
2017
HGF-reported in Year
2017
ISSN (print) / ISBN
0340-6245
Journal
Thrombosis and Haemostasis
Quellenangaben
Volume: 117,
Issue: 12,
Pages: 2369-2375
Publisher
Schattauer
Publishing Place
Stuttgart
Reviewing status
Peer reviewed
POF-Topic(s)
90000 - German Center for Diabetes Research
Research field(s)
Helmholtz Diabetes Center
PSP Element(s)
G-502400-001
G-502400-002
G-502400-002
WOS ID
WOS:000423998200016
PubMed ID
29212124
Erfassungsdatum
2018-01-29