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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

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Interference of the new oral anticoagulant dabigatran with frequently used coagulation tests

1, a / Guenter Weigel2, a / Peter Quehenberger3 / Josef Tomasits4 / Alexander C. Haushofer5 / Gerold Aspoeck6 / Lorin Loacker2 / Mirjam Schnapka-Koepf2 / Georg Goebel7 / Andrea Griesmacher2

1Institute of Laboratory Medicine, Municipal Hospital Hietzing-Rosenhuegel, Vienna, Austria

2Central Institute of Medical and Chemical Laboratory Diagnostics, University Hospital – State Hospital Innsbruck, Innsbruck, Austria

3Clinical Institute of Laboratory Medicine, Medical University Vienna, Vienna, Austria

4Central Laboratory, General Hospital Linz, Linz, Austria

5Central Laboratory, Clinic St. Poelten, St. Poelten, Austria

6Institute of Laboratory Medicine I, Clinic Wels-Grieskirchen, Wels-Grieskirchen, Austria

7Department for Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria

aWMH and GW equally contributed to this work.

Corresponding author: Univ.-Doz. Dr. Walter-Michael Halbmayer, Institute of Laboratory Medicine, Municipal Hospital Hietzing-Rosenhuegel, Wolkersbergenstr. 1, 1130 Vienna, Austria Phone: +43 180110-2088, Fax: +43 180110-2688

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM). Volume 50, Issue 9, Pages 1601–1605, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/cclm-2011-0888, March 2012

Publication History

Received:
2011-11-28
Accepted:
2012-02-06
Published Online:
2012-03-16

Abstract

Background: Dabigatran etexilate is a new oral anticoagulant for the therapy and prophylaxis of venous thromboembolism and stroke prevention in patients with atrial fibrillation. To investigate the extent of interactions of this new anticoagulant with frequently used coagulation assays, we completed a multicenter in vitro trial with Conformité Européenne(CE)-labeled dabigatran-spiked plasma samples.

Methods: Lyophilized plasma samples with dabigatran concentrations ranging from 0.00 to 0.48 μg/mL were sent to the coagulation laboratories of six major Austrian hospitals for evaluation. Coagulation assays were performed under routine conditions using standard reagents and analyzer.

Results: Dabigatran led to a dose-dependent prolongation of the clotting times in coagulometric tests and influenced the majority of the parameters measured. Statistically significant interference could be observed with the prothrombin time (PT), activated partial thromboplastin time (aPTT) and PT/aPTT-based assays (extrinsic/intrinsic factors, APC-resistance test) as well as lupus anticoagulant testing. Even non-clotting tests, such as the colorimetric factor XIII activity assay and to a minor extent the amidolytic antithrombin activity assay (via factor IIa) were affected.

Conclusions: This multicenter trial confirms and also adds to existing data, demonstrating that laboratories should expect to observe strong interferences of coagulation tests with increasing concentrations of dabigatran. This finding might become particularly important in the elderly and in patients with renal impairment as well as patients whose blood is drawn at peak levels of dabigatran.

Keywords: coagulation tests; dabigatran; interference; misinterpretation; new oral anticoagulants

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