Novel methods for assessing oral direct factor xa and thrombin inhibitors: Use of point-of-care testing and urine samples

Seminars in Thrombosis and Hemostasis

Volumn 39, Issue 1, 2013, Pages 66-71

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

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

dabigatran; new oral anticoagulants; point of care method; rivaroxaban; urine

Indexed keywords

BLOOD CLOTTING FACTOR 10A; DABIGATRAN; RIVAROXABAN; THROMBIN INHIBITOR;

ARTICLE; CHROMATOGRAPHY; DRUG EXCRETION; GLOMERULUS FILTRATION; HUMAN; INTOXICATION; KIDNEY FUNCTION; PLASMA; POINT OF CARE TESTING; PREGNANCY; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; THROMBOSIS; URINALYSIS;

ADMINISTRATION, ORAL; ANTICOAGULANTS; BENZIMIDAZOLES; BETA-ALANINE; CLINICAL CHEMISTRY TESTS; FACTOR XA; FEMALE; HUMANS; MALE; MORPHOLINES; POINT-OF-CARE SYSTEMS; PREGNANCY; REPRODUCIBILITY OF RESULTS; THIOPHENES;

EID: 84873405067     PISSN: 00946176     EISSN: 10989064     Source Type: Journal    
DOI: 10.1055/s-0032-1331155     Document Type: Article

References (41)

1. Falck-Ytter Y., Francis C. W., Johanson N. A., et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and Prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest: 2012; 141 2 (Suppl): e278S e325S
2. Roskell N. S., Lip G. Y., Noack H., Clemens A., Plumb J. M. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb Haemost: 2010; 104 6 1106 1115
3. Linkins L. A., Dans A. L., Moores L. K., et al. Treatment and Prevention of Heparin-Induced Thrombocytopenia: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest: 2012; 141 e495S 530S
4. Lip G. Y., Andreotti F., Fauchier L., et al. European Heart Rhythm Association Bleeding risk assessment and management in atrial fibrillation patients. Executive Summary of a Position Document from the European Heart Rhythm Association [EHRA], endorsed by the European Society of Cardiology [ESC] Working Group on Thrombosis. Thromb Haemost: 2011; 106 6 997 1011
5. Schmitt L., Speckman J., Ansell J. Quality assessment of anticoagulation dose management: comparative evaluation of measures of time-in-therapeutic range. J Thromb Thrombolysis: 2003; 15 3 213 216
6. Lader E., Martin N., Cohen G., et al. Warfarin therapeutic monitoring: is 70% time in the therapeutic range the best we can do? J Clin Pharm Ther: 2012; 37 4 375 377
7. Harenberg J., Marx S., Krejczy M., Wehling M. New anticoagulants - promising and failed developments. Br J Pharmacol: 2012; 165 2 363 372
8. Ten Cate H. Monitoring new oral anticoagulants, managing thrombosis, or both? Thromb Haemost: 2012; 107 5 803 805
9. Mismetti P., Laporte S. New oral antithrombotics: a need for laboratory monitoring. For. J Thromb Haemost: 2010; 8 4 621 626
10. 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
11. Favaloro E. J., Lippi G., Koutts J. Laboratory testing of anticoagulants: the present and the future. Pathology: 2011; 43 7 682 692
12. Favaloro E. J., Lippi G. Laboratory testing and/or monitoring of the new oral anticoagulants/antithrombotics: for and against? Clin Chem Lab Med: 2011; 49 5 755 757
13. Anderson J. L., Adams C. D., Antman E. M., et al. American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation: 2007; 116 7 e148 e304
14. Tomonaga Y., Gutzwiller F., Lüscher T. F., et al. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial. BMC Fam Pract: 2011; 12 12
15. Sidelmann J. J., Gram J., Larsen A., Overgaard K., Jespersen J. Analytical and clinical validation of a new point-of-care testing system for determination of D-dimer in human blood. Thromb Res: 2010; 126 6 524 530
16. Van Cott E. M. Point-of-care testing in coagulation. Clin Lab Med: 2009; 29 3 543 553
17. Jespersen J., Poller L., van den Besselaar A. M., et al. External quality assessment (EQA) for CoaguChek monitors. Thromb Haemost: 2010; 103 5 936 941
18. Chen F., Maridakis V., O'neill E. A., et al. A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Platelets: 2012; 23 4 249 258
19. Görlinger K., Dirkmann D., Hanke A. A., et al. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology: 2011; 115 6 1179 1191
20. Kubitza D., Becka M., Mueck W., et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol: 2010; 70 5 703 712
21. Poulsen B. K., Grove E. L., Husted S. E. New oral anticoagulants: a review of the literature with particular emphasis on patients with impaired renal function. Drugs: 2012; 72 13 1739 1753
22. Harenberg J., Kraemer R. Direct thrombin inhibitors. International Patent Application No. PCT/EP2012/002540
23. 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
24. Harenberg J., Giese C., Marx S., Krämer R. Determination of dabigatran in human plasma samples. Semin Thromb Hemost: 2012; 38 1 16 22
25. Feinstein A. R., Cicchetti D. V. High agreement but low kappa: I. The problems of two paradoxes. J Clin Epidemiol: 1990; 43 6 543 549
26. Hasnain M., Onishi H., Elstein A. S. Inter-rater agreement in judging errors in diagnostic reasoning. Med Educ: 2004; 38 6 609 616
27. Böhning D., Holling H., Patilea V. A limitation of the diagnostic-odds ratio in determining an optimal cut-off value for a continuous diagnostic test. Stat Methods Med Res: 2011; 20 5 541 550
28. Harenberg J., Kraemer R. Direct factor Xa inhibitors. International Patent No. PCT/EP2011/WO2012/06913A1
29. Harenberg J., Erdle S., Marx S., Krämer R. Determination of rivaroxaban in human plasma samples. Semin Thromb Hemost: 2012; 38 2 178 184
30. Harenberg J., Marx S., Weiss C., Krämer R., Samama M., Schulman S. on behalf of the working party: methods to determine rivaroxaban of the 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
31. Tripodi A. Problems and solutions for testing hemostasis assays while patients are on anticoagulants. Semin Thromb Hemost: 2012; 38 6 586 592
32. Mahler C., Hermann K., Horne R., et al. Assessing reported adherence to pharmacological treatment recommendations. Translation and evaluation of the Medication Adherence Report Scale (MARS) in Germany. J Eval Clin Pract: 2010; 16 3 574 579
33. Attema-de Jonge M. E., Peeters S. Y., Franssen E. J. Performance of three point-of-care urinalysis test devices for drugs of abuse and therapeutic drugs applied in the emergency department. J Emerg Med: 2012; 42 6 682 691
34. Cervinski M. A., Lockwood C. M., Ferguson A. M., et al. Qualitative point-of-care and over-the-counter urine hCG devices differentially detect the hCG variants of early pregnancy. Clin Chim Acta: 2009; 406 1-2 81 85
35. Cramer J. A. A systematic review of adherence with medications for diabetes. Diabetes Care: 2004; 27 5 1218 1224
36. Huser M. A., Evans T. S., Berger V. Medication adherence trends with statins. Adv Ther: 2005; 22 2 163 171
37. Burkhart P. V., Sabaté E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh: 2003; 35 3 207
38. Horne R., Weinmann J., Barber N. Concordance, Adherence and Compliance in Medicine Taking. London, England National Co-ordinating Centre for NHS Service Delivery and Organisation Research and Development (NCCDSO): 2005
39. Tabrizi J. S., Wilson A. J., Coyne E. T., O'Rourke P. K. Clients' perspective on service quality for type 2 diabetes in Australia. Aust N Z J Public Health: 2007; 31 6 511 515
40. Kaplan S. H., Greenfield S., Ware J. E. Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care: 1989; 27 3, Suppl S110 S127
41. Delaney B. C., Hyde C. J., McManus R. J., et al. Systematic review of near patient test evaluations in primary care. BMJ: 1999; 319 7213 824 827