Determination of dabigatran in plasma, serum, and urine samples: Comparison of six methods

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 8, 2015, Pages 1237-1247

  Du, Shanshan ^a   Weiss, Christel ^a   Christina, Giese ^a   Krämer, Sandra ^a   Wehling, Martin ^a   Krämer, Roland ^a   Harenberg, Job ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

chromogenic substrate methods; clotting time assays; dabigatran; plasma; serum; urine

Indexed keywords

CHROMOGENIC SUBSTRATE; DABIGATRAN; ANTITHROMBIN; ECARIN; PROTEINASE;

ARTICLE; BLOOD CLOTTING PARAMETERS; BLOOD CLOTTING TIME; BLOOD SAMPLING; CREATININE CLEARANCE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG URINE LEVEL; ECARIN CLOTTING TIME; HEMOCLOT THROMBIN INHIBITOR ASSAY; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; PARTIAL THROMBOPLASTIN TIME; PRIORITY JOURNAL; PROTHROMBINASE INDUCED CLOTTING TIME; URINALYSIS; BLOOD; BLOOD CLOTTING; BLOOD CLOTTING TEST; CHEMISTRY; COMPARATIVE STUDY; DRUG EFFECTS; METABOLISM; URINE;

ANTITHROMBINS; BLOOD COAGULATION; BLOOD COAGULATION TESTS; CHROMOGENIC COMPOUNDS; DABIGATRAN; ENDOPEPTIDASES; HUMANS;

EID: 84934326355     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2014-0991     Document Type: Article

References (45)

1. Hauel NH, Nar H, Priepke H, Ries U, Stassen J-M, Wienen W. Structure-based design of novel potent nonpeptide thrombin inhibitors. J Med Chem 2002;45:1757-66.
2. Coppens M, Eikelboom JW, Gustafsson D, Weitz JI, Hirsh J. Translational success stories development of direct thrombin inhibitors. Circ Res 2012;111:920-9.
3. Delavenne X, Moracchini J, Laporte S, Mismetti P, Basset T. UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma. J Pharmaceut Biomed 2012;58:152-6.
4. Hylek EM, Ko D, Cove CL. Gaps in translation from trials to practice: non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation. Thrombosis and haemostasis 2014;111:783-8.
5. Stangier J, Stahle H, Rathgen K, Roth W, Reseski K, Kornicke T. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, with coadministration of digoxin. J Clin Pharmacol 2012;52:243-50.
6. Tahir F, Riaz H, Riaz T, Badshah MB, Riaz IB, Hamza A, et al. The new oral anti-coagulants and the phase 3 clinical trials - a systematic review of the literature. Thromb J 2013;11:1-8.
7. Agency EM. Summary of product characteristic: Pradaxa. In: EU EMA, editor, 2013.
8. Harder S, Graff J. Novel oral anticoagulants: clinical pharmacology, indications and practical considerations. Eur J Clin Pharmacol 2013;69:1617-33.
9. Pare G, Eriksson N, Lehr T, Connolly S, Eikelboom J, Ezekowitz MD, et al. Genetic determinants of dabigatran plasma levels and their relation to bleeding. Circulation 2013;127:1404-12.
10. Skeppholm M, Hjemdahl P, Antovic JP, Muhrbeck J, Eintrei J, Ronquist-Nii Y, et al. On the monitoring of dabigatran treatment in "real life" patients with atrial fibrillation. Thromb Res 2014;134:783-9.
11. Antovic JP, Skeppholm M, Eintrei J, Boija EE, Soderblom L, Norberg EM, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol 2013;69:1875-81.
12. Douxfils J, Dogne JM, Mullier F, Chatelain B, Ronquist-Nii Y, Malmstrom RE, et al. Comparison of calibrated dilute thrombin time and aPTT tests with LC-MS/MS for the therapeutic monitoring of patients treated with dabigatran etexilate. Thromb Haemost 2013;110:543-9.
13. Stangier J, Feuring M. Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis 2012;23:138-43.
14. Brunetti L, Bandali F. Dabigatran: is there a role for coagulation assays in guiding therapy? Ann Pharmacother 2013;47:828-40.
15. Bates SM, Weitz JI. Coagulation assays. Circulation 2005;112:e53-60.
16. Tripodi A. The laboratory and the direct oral anticoagulants. Blood 2013;121:4032-5.
17. Douxfils J, Mullier F, Robert S, Chatelain C, Chatelain B, Dogne JM. Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate. Thromb Haemost 2012;107:985-97.
18. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, et al. Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103:1116-27.
19. Hapgood G, Butler J, Malan E, Chunilal S, Tran H. The effect of dabigatran on the activated partial thromboplastin time and thrombin time as determined by the Hemoclot thrombin inhibitor assay in patient plasma samples. Thromb Haemost 2013;110:308-15.
20. Harenberg J, Kraemer S, Du S, Giese C, Schulze A, Kraemer R, et al. Determination of direct oral anticoagulants from human serum samples. Semin Thromb Hemost 2014;40:129-34.
21. Harenberg J, Du S, Kramer S, Giese C, Schulze A, Weiss C, et al. Novel methods for assessing oral direct factor Xa and thrombin inhibitors: use of point-of-care testing and urine samples. Semin Thromb Hemost 2013;39:66-71.
22. Harenberg J, Kramer S, Du S, Zolfaghari S, Schulze A, Kramer R, et al. Measurement of rivaroxaban and apixaban in serum samples of patients. Eur J Clin Invest 2014;44:743-52.
23. Harenberg J, Giese C, Marx S, Kramer R. Determination of dabigatran in human plasma samples. Semin Thromb Hemost 2012;38:16-22.
24. Rosen S. Chromogenic methods in coagulation diagnostics. Haemostaseologie 2005;25:259-66.
25. Nurmohamed MT, Berckmans RJ, Morrien-Salomons WM, Berends F, Hommes DW, Rijnierse JJ, et al. Monitoring anticoagulant therapy by activated partial thromboplastin time: hirudin assessment. An evaluation of native blood and plasma assays. Thromb Haemost 1994;72:685-92.
26. Fenyvesi T, Jorg I, Weiss C, Harenberg J. Effects of vitamin K antagonist phenprocoumon on activated partial thromboplastin time measurement of direct thrombin inhibitors. Blood Coagul Fibrinolysis 2004;15:605-11.
27. Calatzis A, Peetz D, Haas S, Spannagl M, Rudin K, Wilmer M. Prothrombinase-induced clotting time assay for determination of the anticoagulant effects of unfractionated and low-molecular-weight heparins, fondaparinux, and thrombin inhibitors. Am J Clin Pathol 2008;130:446-54.
28. Calatzis A, Spannagl M, Gempeler-Messina P, Kolde H, Schramm W, Haas S. The prothrombinase-induced clotting test: A new technique for the monitoring of anticoagulants. Pathophysiol Haemost and Thromb 2004;30(Suppl 2):172-4.
29. Harenberg J, Giese C, Hagedorn A, Traeger I, Fenyvesi T. Determination of antithrombin-dependent factor Xa inhibitors by prothrombin-induced clotting time. Semin Thromb Hemost 2007;33:503-7.
30. Nowak G. The ecarin clotting time, a universal method to quantify direct thrombin inhibitors. Pathophysiol Haemost Thromb 2003-2004;33:173-83.
31. Fenyvesi T, Jorg I, Weiss C, Harenberg J. Effects of lepirudin, argatroban and melagatran and additional influence of phenprocoumon on ecarin clotting time. Thromb Res 2003;111:89-94.
32. Lange U, Nowak G, Bucha E. Ecarin chromogenic assay - a new method for quantitative determination of direct thrombin inhibitors like hirudin. Pathophysiol Haemost Thromb 2003-2004;33:184-91.
33. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979;86:420-8.
34. Diamandopoulos A, Goudas P, Arvanitis A. Comparison of estimated creatinine clearance among five formulae (Cockroft-Gault, Jelliffe, Sanaka, simplified 4-variable MDRD and DAF) and the 24 hours-urine-collection creatinine clearance. Hippokratia 2010;14:98-104.
35. Hawes EM, Deal AM, Funk-Adcock D, Gosselin R, Jeanneret C, Cook AM, et al. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost 2013;11:1493-502.
36. Douxfils J, Chatelain C, Chatelain B, Dogne JM, Mullier F. Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide. Thromb Haemost 2013;110: 283-94.
37. Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013;369:1206-14.
38. Lottenberg R, Hall JA, Blinder M, Binder EP, Jackson CM. The action of thrombin on peptide p-nitroanilide substrates. Substrate selectivity and examination of hydrolysis under different reaction conditions. Biochim Biophys Acta 1983;742:539-57.
39. Kolde HJ, Eberle R, Heber H, Heimburger N. New chromogenic substrates for thrombin with increased specificity. Thromb Haemost 1986;56:155-9.
40. Gray E, Harenberg J. Collaborative study on monitoring methods to determine direct thrombin inhibitors lepirudin and argatroban. J Thromb Haemost 2005;3:2096-7.
41. Harenberg J, Kramer S, Du S, Weiss C, Kramer R. Concept of a point of care test to detect new oral anticoagulants in urine samples. Thromb J 2013;11:1-5.
42. Mani H, Herth N, Kasper A, Wendt T, Schuettfort G, Weil Y, et al. Point-of-care coagulation testing for assessment of the pharmacodynamic anticoagulant effect of direct oral anticoagulant. Ther Drug Monit 2014;36:624-31.
43. Krummenauer F, Doll G. Statistical methods for the comparison of measurements derived from orthodontic imaging. Eur J Orthod 2000;22:257-269.
44. Harenberg J, Du S, Weiss C, Kramer R, Hoppensteadt D, Walenga J. Report of the Subcommittee on Control of Anticoagulation on the determination of the anticoagulant effects of apixaban: communication from the SSC of the ISTH. J Thromb Haemost 2014;12:801-4.
45. Harenberg J, Krämer R. Determination of direct thrombin inhibitors in fluids like serum or urine. Google Patents, 2012.