Is Thrombin Time useful for the assessment of dabigatran concentrations? An in vitro and ex vivo study

Thrombosis Research

Volumn 136, Issue 3, 2015, Pages 693-696

  Lessire, Sarah ^a,b   Douxfils, Jonathan ^b   Baudar, Justine ^a   Bailly, Nicolas ^a   Dincq, Anne Sophie ^a   Gourdin, Maximilien ^a   Dogné, Jean Michel ^b   Chatelain, Bernard ^a   Mullier, François ^a,b  

^a UNIVERSITY HOSPITAL OF MONT GODINNE   (Belgium)

^b University of Namur   (Belgium)

Author keywords

Abbreviations HTI Hemoclot Thombin Inhibitors ; CV Coefficient of variation expressed in percentage; ECA Ecarin chromogenic assay; LOD Limit of detection; LOQ Limit of quantification; NIH ml National Institutes of Health (NIH) units per ml; NPP Normal pool plasma; OTC Optimal thrombin concentration; PPP Platelet poor plasma; SD Standard deviation; TMAX Limit of measurement of thrombin time; TT Thrombin time; UFH Unfractionated heparin

Indexed keywords

DABIGATRAN; REAGENT; THROMBIN; ANTITHROMBIN;

BLOOD SAMPLING; COAGULOMETER; DRUG BLOOD LEVEL; HUMAN; LETTER; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PLASMA; PREOPERATIVE PERIOD; PRIORITY JOURNAL; ROOM TEMPERATURE; THROMBIN TIME; BLOOD; BLOOD CLOTTING; DRUG EFFECTS; DRUG MONITORING; IN VITRO STUDY; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; THROMBOSIS;

ANTITHROMBINS; BLOOD COAGULATION; DABIGATRAN; DRUG MONITORING; HUMANS; IN VITRO TECHNIQUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; THROMBIN TIME; THROMBOSIS;

EID: 84940440202     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2015.07.018     Document Type: Letter

References (22)

1. J. Douxfils, F. Mullier, S. Robert, C. Chatelain, B. Chatelain, and J.M. Dogne Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate Thromb. Haemost. 107 2012 985 997 10.1160/TH11-11-0804
2. J. Douxfils, J.M. Dogne, F. Mullier, B. Chatelain, Y. Ronquist-Nii, R.E. Malmstrom, and P. Hjemdahl 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. 110 2013 543 549 10.1160/TH13-03-0202
3. R.C. Gosselin, D.M. Dwyre, and W.E. Dager Measuring dabigatran concentrations using a chromogenic ecarin clotting time assay Ann. Pharmacother. 47 2013 1635 1640 10.1177/1060028013509074
4. J.P. Antovic, M. Skeppholm, J. Eintrei, E.E. Boija, L. Soderblom, E.M. Norberg, L. Onelov, Y. Ronquist-Nii, A. Pohanka, O. Beck, P. Hjemdahl, and R.E. Malmstrom Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma Eur. J. Clin. Pharmacol. 69 2013 1875 1881 10.1007/s00228-013-1550-4
5. E.M. Hawes, A.M. Deal, D. Funk-Adcock, R. Gosselin, C. Jeanneret, A.M. Cook, J.M. Taylor, H.C. Whinna, A.M. Winkler, and S. Moll 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. 11 2013 1493 1502 10.1111/jth.12308
6. J. Douxfils, S. Lessire, A.S. Dincq, P. Hjemdahl, Y. Ronquist-Nii, A. Pohanka, M. Gourdin, B. Chatelain, J.M. Dogne, and F. Mullier Estimation of dabigatran plasma concentrations in the perioperative setting. An ex vivo study using dedicated coagulation assays Thromb. Haemost. 113 2014 10.1160/TH14-09-0808
7. L. Stang, S. Nahirniak, K. Butcher, and A.J. Szkotak Dabigatran assessment in patients with acute complications using routine coagulation assays Blood Coagul. Fibrinolysis 25 2014 426 434 10.1097/MBC.0000000000000056
8. G. Hapgood, J. Butler, E. Malan, S. Chunilal, and H. Tran 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. 110 2013 308 315 10.1160/TH13-04-0301
9. A. Cuker, D.M. Siegal, M.A. Crowther, and D.A. Garcia Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants J. Am. Coll. Cardiol. 64 2014 1128 1139 10.1016/j.jacc.2014.05.065
10. J. van Ryn, J. Stangier, S. Haertter, K.H. Liesenfeld, W. Wienen, M. Feuring, and A. Clemens Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity Thromb. Haemost. 103 2010 1116 1127 10.1160/TH09-11-0758
11. M.M. Flanders, R. Crist, and G.M. Rodgers Comparison of five thrombin time reagents Clin. Chem. 49 2003 169 172
12. R.A. Marlar, J.N. Gausman, and J.W. Engel Validation of hemostasis and coagulation assays: recommendations and guidelines Semin. Thromb. Hemost. 40 2014 186 194 10.1055/s-0033-1364186
13. W. Chandler Initial evaluation of hemostasis: reagent and method selection S. Kitchen, J. Olson, F. Prestion, Quality in Laboratory Hemostasis and Thrombosis 2013 95 104
14. G. Pernod, P. Albaladejo, A. Godier, C.M. Samama, S. Susen, Y. Gruel, N. Blais, P. Fontana, A. Cohen, J.V. Llau, N. Rosencher, J.F. Schved, E. de Maistre, M.M. Samama, P. Mismetti, and P. Sie Working Group on Perioperative H. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013 Arch. Cardiovasc. Dis. 106 2013 382 393 10.1016/j.acvd.2013.04.009
15. European Medicines Agency C. Pradaxa - EMEA/H/C/000829/X/13/G. (CHMP) CfMPfHU, 2011.
16. P.A. Reilly, T. Lehr, S. Haertter, S.J. Connolly, S. Yusuf, J.W. Eikelboom, M.D. Ezekowitz, G. Nehmiz, S. Wang, L. Wallentin, and R.-L. Investigators The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) J. Am. Coll. Cardiol. 63 2014 321 328 10.1016/j.jacc.2013.07.104
17. I.J. Mackie Kitchen S, Machin SJ, Lowe GD, Haemostasis, Thrombosis Task Force of the British Committee for Standards in H. Guidelines on fibrinogen assays Br. J. Haematol. 121 2003 396 404
18. M.T. Cunningham, J.D. Olson, W.L. Chandler, E.M. Van Cott, C.S. Eby, J. Teruya, S.C. Hollensead, D.M. Adcock, P.M. Allison, K.K. Kottke-Marchant, and M.D. Smith External quality assurance of fibrinogen assays using normal plasma: results of the 2008 College of American Pathologists proficiency testing program in coagulation Arch. Pathol. Lab. Med. 136 2012 789 795 10.5858/arpa.2011-0322-OA
19. V. Ignjatovic Thrombin clotting time Methods Mol. Biol. 992 2013 131 138 10.1007/978[--]1-62703-339-8-10
20. M.A. Inchiosa Jr., S. Pothula, K. Kubal, V.T. Sanchala, and I. Navarro Toward development of a point-of-care assay of enoxaparin anticoagulant activity in whole blood J. Thromb. Thrombolysis 32 2011 47 53 10.1007/s11239-010-0546-5
21. P.K. Chin, D.F. Wright, D.M. Patterson, M.P. Doogue, and E.J. Begg A proposal for dose-adjustment of dabigatran etexilate in atrial fibrillation guided by thrombin time Br. J. Clin. Pharmacol. 78 2014 599 609 10.1111/bcp.12364
22. J. Douxfils, F. Mullier, and J.M. Dogne Dose tailoring of dabigatran etexilate: obvious or excessive? Expert Opin. Drug Saf. 1-7 2015 10.1517/14740338.2015.1049995