Determination of direct oral anticoagulants from human serum samples

Seminars in Thrombosis and Hemostasis

Volumn 40, Issue 1, 2014, Pages 129-134

  Harenberg, Job ^a   Kraemer, Sandra ^a   Du, Shanshan ^a   Giese, Christina ^a   Schulze, Astrid ^a   Kraemer, Roland ^a   Weiss, Christel ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

apixaban; dabigatran; direct oral anticoagulants; methods; rivaroxaban; serum

Indexed keywords

APIXABAN; DABIGATRAN ETEXILATE; RIVAROXABAN;

ANALYTICAL ERROR; ANTICOAGULANT THERAPY; ARTICLE; AUTOMATION; COLORIMETRY; CONTROLLED STUDY; DILUTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; HUMAN; PHOTOMETRY; PRIORITY JOURNAL; THROMBOCYTE POOR PLASMA;

ADMINISTRATION, ORAL; ADULT; AGED; ANTICOAGULANTS; FACTOR XA; FEMALE; HUMANS; MALE; MIDDLE AGED; MORPHOLINES; PREGNANCY; PYRAZOLES; PYRIDONES; THIOPHENES; THROMBIN;

EID: 84893699027     PISSN: 00946176     EISSN: 10989064     Source Type: Journal    
DOI: 10.1055/s-0033-1363462     Document Type: Article

References (37)

1. Lippi G., Salvagno G. L., Montagnana M., Lima-Oliveira G., Guidi G. C., Favaloro E. J. Quality standards for sample collection in coagulation testing. Semin Thromb Hemost: 2012; 38 6 565 575
2. Juenke J. M., Brown P. I., Urry F. M., Johnson-Davis K. L., McMillin G. A. Simultaneous UPLC-MS/MS assay for the detection of the traditional antipsychotics haloperidol, fluphenazine, perphenazine, and thiothixene in serum and plasma. Clin Chim Acta: 2013; 423 1 32 34
3. Wu A. H., McKay C., Broussard L. A., et al. National Academy of Clinical Biochemistry Laboratory Medicine. National academy of clinical biochemistry laboratory medicine practice guidelines: recommendations for the use of laboratory tests to support poisoned patients who present to the emergency department. Clin Chem: 2003; 49 3 357 379
4. Bush D. M. The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: current status and future considerations. Forensic Sci Int: 2008; 174 2-3 111 119
5. Gray E., Hogwood J., Mulloy B. The anticoagulant and antithrombotic mechanisms of heparin. Handbook Exp Pharmacol: 2012; 207 207 43 61
6. Fischer B. E., Schlokat U., Himmelspach M., Dorner F. Binding of hirudin to meizothrombin. Protein Eng: 1998; 11 8 715 721
7. Hu Z. Y., Parker R. B., Herring V. L., Laizure S. C. Conventional liquid chromatography/triple quadrupole mass spectrometry based metabolite identification and semi-quantitative estimation approach in the investigation of in vitro dabigatran etexilate metabolism. Anal Bioanal Chem: 2013; 405 5 1695 1704
8. Rohde G. Determination of rivaroxaban-a novel, oral, direct Factor Xa inhibitor-in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci: 2008; 872 (1-2): 43 50
9. He K., Luettgen J. M., Zhang D., et al. Preclinical pharmacokinetics and pharmacodynamics of apixaban, a potent and selective factor Xa inhibitor. Eur J Drug Metab Pharmacokinet: 2011; 36 3 129 139
10. Harenberg J., Giese C., Marx S., Krämer R. Determination of dabigatran in human plasma samples. Semin Thromb Hemost: 2012; 38 1 16 22
11. Harenberg J., Marx S., Weiss C., Krämer R., Samama M., Schulman S.; Subcommittee on Control of Anticoagulation of the ISTH. Report of the Subcommittee of Control of Anticoagulation on the determination of the anticoagulant effects of rivaroxaban. J Thromb Haemost: 2012; 10 7 1433 1436
12. Harenberg J., Kraemer R. Direct thrombin inhibitors. International patent application No PCT/EP2012/002540. 2012
13. Gray E., Harenberg J.; ISTH Control of Anticoagulation SSC Working Group on Thrombin Inhibitors. Collaborative study on monitoring methods to determine direct thrombin inhibitors lepirudin and argatroban. J Thromb Haemost: 2005; 3 9 2096 2097
14. Harenberg J., Kraemer R. Direct factor Xa inhibitors. International Patent Application PCT/EP2011/005586. 2011
15. Marin S. J., Roberts M., Wood M., McMillin G. A. Sensitive UPLC-MS-MS assay for 21 benzodiazepine drugs and metabolites, zolpidem and zopiclone in serum or plasma. J Anal Toxicol: 2012; 36 7 472 476
16. Couchman L., Birch M., Ireland R., et al. An automated method for the measurement of a range of tyrosine kinase inhibitors in human plasma or serum using turbulent flow liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem: 2012; 403 6 1685 1695
17. Theurillat R., Sendi P., Thormann W. An MEKC assay for the therapeutic drug monitoring of cefepime. J Sep Sci: 2013; 36 17 2915 2921
18. Olives A. I., González-Ruiz V., Martín M. A. Isolation and quantitative methods for analysis of non-steroidal anti-inflammatory drugs. Antiinflamm Antiallergy Agents Med Chem: 2012; 11 1 65 95
19. Connolly S. J., Ezekowitz M. D., Yusuf S., et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med: 2009; 361 12 1139 1151
20. Patel M. R., Mahaffey K. W., Garg J., et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med: 2011; 365 10 883 891
21. Granger C. B., Alexander J. H., McMurray J. J., et al. ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med: 2011; 365 11 981 992
22. Liesenfeld K. H., Schäfer H. G., Trocóniz I. F., Tillmann C., Eriksson B. I., Stangier J. Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis. Br J Clin Pharmacol: 2006; 62 5 527 537
23. Clemens A., Haertter S., Friedman J., et al. Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification. Curr Med Res Opin: 2012; 28 2 195 201
24. Mueck W., Borris L. C., Dahl O. E., et al. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost: 2008; 100 3 453 461
25. Mueck W., Lensing A. W., Agnelli G., Decousus H., Prandoni P., Misselwitz F. Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet: 2011; 50 10 675 686
26. Tanigawa T., Kaneko M., Hashizume K., et al. Model-based dose selection for phase III rivaroxaban study in Japanese patients with non-valvular atrial fibrillation. Drug Metab Pharmacokinet: 2013; 28 1 59 70
27. Becker R. C., Alexander J. H., Newby L. K., et al. Effect of apixaban, an oral and direct factor Xa inhibitor, on coagulation activity biomarkers following acute coronary syndrome. Thromb Haemost: 2010; 104 5 976 983
28. Harenberg J., Giese C., Marx S., Krämer R. Determination of dabigatran in human plasma samples. Semin Thromb Hemost: 2012; 38 1 16 22
29. Samama M. M., Guinet C., Le Flem L., Ninin E., Debue J. M. Measurement of dabigatran and rivaroxaban in primary prevention of venous thromboembolism in 106 patients, who have undergone major orthopedic surgery: an observational study. J Thromb Thrombolysis: 2013; 35 2 140 146
30. 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 2 308 315
31. Harenberg J., Erdle S., Marx S., Krämer R. Determination of rivaroxaban in human plasma samples. Semin Thromb Hemost: 2012; 38 2 178 184
32. Douxfils J., Tamigniau A., Chatelain B., et al. Comparison of calibrated chromogenic anti-Xa assay and PT tests with LC-MS/MS for the therapeutic monitoring of patients treated with rivaroxaban. Thromb Haemost: 2013; 110 4 723 731
33. Mueck W., Schwers S., Stampfuss J. Rivaroxaban and other novel oral anticoagulants: pharmacokinetics in healthy subjects, specific patient populations and relevance of coagulation monitoring. Thromb J: 2013; 11 1 10
34. Frost C., Nepal S., Wang J., et al. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmacol: 2013; 76 5 776 786
35. Mismetti P., Laporte S. New oral antithrombotics: a need for laboratory monitoring. For. J Thromb Haemost: 2010; 8 4 621 626
36. Harenberg J., Marx S., Erdle S., Krämer R. Determination of the anticoagulant effects of new oral anticoagulants: an unmet need. Expert Rev Hematol: 2012; 5 1 107 113
37. Nagler M., Bachmann L. M., Alberio L., et al. Variability between laboratories performing coagulation tests with identical platforms: a nationwide evaluation study. Thromb J: 2013; 11 1 6