Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: Results of a multicenter field trial

Clinical and Applied Thrombosis/Hemostasis

Volumn 18, Issue 2, 2012, Pages 150-158

  Samama, Meyer Michel ^a,b   Contant, Genevieve ^c   Spiro, Theodore E ^d   Perzborn, Elisabeth ^e   Flem, Lena Le ^b   Guinet, Céline ^b   Gourmelin, Yves ^c   Martinoli, Jean Luc ^c  

^a HÔTEL DIEU   (France)

^b Biomnis Laboratories R and D   (France)

^c Diagnostica Stago SA   (France)

^d Bayer HealthCare Pharmaceuticals Inc   (United States)

^e BAYER PHARMA AG   (Germany)

Author keywords

calibrators; plasma level; prothrombin time; rivaroxaban

Indexed keywords

RIVAROXABAN;

ACCURACY; ARTICLE; CALIBRATION; CONCENTRATION (PARAMETERS); DRUG BLOOD LEVEL; LABORATORY TEST; PRIORITY JOURNAL; PROTHROMBIN TIME; REPRODUCIBILITY; VALIDATION STUDY;

ANTICOAGULANTS; BLOOD PRESERVATION; CALIBRATION; DRUG MONITORING; DRUG STABILITY; EUROPE; FACTOR VIIA; FEASIBILITY STUDIES; FREEZE DRYING; HUMANS; INDICATORS AND REAGENTS; LABORATORY PROFICIENCY TESTING; MORPHOLINES; NORTH AMERICA; OSMOLAR CONCENTRATION; PLASMA; PROTHROMBIN TIME; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; THIOPHENES;

EID: 84856293397     PISSN: 10760296     EISSN: 19382723     Source Type: Journal    
DOI: 10.1177/1076029611426282     Document Type: Article

References (24)

1. Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939-an oral, direct factor Xa inhibitor. J Thromb Haemost. 2005 ; 3 (3). 514-521 (Pubitemid 41632877)
2. Depasse F, Busson J, Mnich J, Le Flem L, Gerotziafas GT, Samama MM.. Effect of BAY 59-7939-a novel, oral, direct Factor Xa inhibitor-on clot-bound factor Xa activity in vitro. J Thromb Haemost. 2005 ; 3 ( suppl 1 ):
3. Mueck W, Becka M, Kubitza D, Voith B, Zuehlsdorf M.. Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct factor Xa inhibitor-in healthy subjects. Int J Clin Pharmacol Ther. 2007 ; 45 (6). 335-344 (Pubitemid 46895052)
4. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct factor Xa inhibitor-in patients undergoing major orthopaedic surgery. Clin Pharmacokinet. 2008 ; 47 (3). 203-216
5. Mueck W, Borris LC, Dahl OE, 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
6. Samama MM, Le Flem L, Guinet C, Depasse F, Perzborn E, VanRyn J.. Comparative responses of some clotting assays to fondaparinux, dabigatran and rivaroxaban. Pathophysiol Haemost Thromb. 2008 ; 36 (suppl 1). P98 - P99
7. Samama MM, Martinoli JL, Le Flem L, et al. Assessment of laboratory assays to measure rivaroxaban-an oral, direct factor Xa inhibitor. Thromb Haemost. 2010 ; 103 (4). 815-825
8. Smith SA, Morrissey JH.. Thromboplastin composition affects the sensitivity of prothrombin time (PT) clotting tests to direct factor Xa inhibitors. Blood (ASH Annual Meeting Abstracts). 2007 ; 110 :
9. 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
10. Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G.. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther. 2005 ; 78 (4). 412-421 (Pubitemid 41393676)
11. Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M.. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939-an oral, direct factor Xa inhibitor-after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005 ; 61 (12). 873-880 (Pubitemid 41803696)
12. Bounameaux H, Reber G.. New oral antithrombotics: a need for laboratory monitoring. Against. J Thromb Haemost. 2010 ; 8 (4). 627-630
13. Mismetti P, Laporte S.. New oral antithrombotics: a need for laboratory monitoring. J Thromb Haemost. 2010 ; 8 (4). 621-626
14. Kubitza D, Becka M, Mueck W, Zuehlsdorf M.. Aspirin has no effect on the safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 59-7939-an oral, direct factor Xa inhibitor. J Thromb Haemost. 2005 ; 3 ( suppl 1 ):
15. Kubitza D, Becka M, Zuehlsdorf M, Mueck W.. Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct factor Xa inhibitor, in healthy subjects. J Clin Pharmacol. 2006 ; 46 (5). 549-558
16. Kubitza D, Becka M, Zuehlsdorf M, Mueck W.. No interaction between the novel, oral direct factor Xa inhibitor BAY 59-7939 and digoxin. J Clin Pharmacol. 2006 ; 46 (5). 702
17. Kubitza D, Becka M, Mueck W, Zuehlsdorf M.. Rivaroxaban (BAY 59-7939)-an oral, direct factor Xa inhibitor-has no clinically relevant interaction with naproxen. Br J Clin Pharmacol. 2007 ; 63 (4). 469-476 (Pubitemid 46426627)
18. Kubitza D, Becka M, Mueck W, Zuehlsdorf M.. Co-administration of rivaroxaban-a novel, oral, direct factor Xa inhibitor-and clopidogrel in healthy subjects. Eur Heart J. 2007 ; 28 (suppl 1). 189
19. Bayer Schering Pharma AG. Xarelto Summary of Product Characteristics. 2011. http://www.xarelto.com/html/downloads/Xarelto-Summary-of-Product- Characteristics-Jan2011. Accessed October 13, 2011.
20. Tripodi A, Chantarangkul V, Guinet C, Samama MM.. The International Normalized Ratio calibrated for rivaroxaban has the potential to normalize prothrombin time results for rivaroxaban-treated patients: results of an in vitro study. J Thromb Haemost. 2011 ; 9 (1). 226-228
21. Morrissey JH, Macik BG, Neuenschwander PF, Comp PC.. Quantitation of activated factor VII levels in plasma using a tissue factor mutant selectively deficient in promoting factor VII activation. Blood. 1993 ; 81 (3). 734-744 (Pubitemid 23040866)
22. Karst A, Bakowski-Enzian B, Perzborn E.. Monitoring of rivaroxaban: suitability of a well-established chromogenic anti-factor Xa assay. J Thromb Haemost. 2009 ; 7 (suppl 2). 372
23. Kitchen S, Preston FE.. Standardization of prothrombin time for laboratory control of oral anticoagulant therapy. Semin Thromb Hemost. 1999 ; 25 (1). 17-25
24. Kubitza D, Becka M, Roth A, Mueck W.. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin. 2008 ; 24 (10). 2757-2765