The perioperative management of dabigatran is challenging, and recommendations based on activated partial thromboplastin time (aPTT) and thrombin time (TT) are unsatisfactory. Dedicated coagulation tests have limitations at plasma concentrations < 50 ng/ml. Therefore, a more sensitive test, which is available 24/7, is required. It was the aim of this study to investigate the performance of the Hemoclot Thrombin Inhibitors® LOW (HTI LOW) kit, a diluted thrombin time, and the STA® – ECA II (ECA-II) kit, a chromogenic variant of the ecarin clotting time, that were developed to measure low dabigatran concentrations, compared to reference dabigatran analysis by liquid chromatography tandem mass-spectrometry (LC-MS/MS). This study included 33 plasma samples from patients treated with dabigatran etexilate who had plasma concentrations < 200 ng/ml. HTI LOW and ECA-II were performed along with HTI, aPTT (STA®-C. K.Prest® and SynthasIL ®) and TT (STA® – Thrombin). All procedures were performed according to recommendations by the manufacturers. Linear (or curvilinear) correlations and Bland-Altman analyses were calculated. For free dabigatran concentrations < 50 ng/ml, the R<sup>2</sup> of linear correlations were 0.69, 0.84 and 0.61, with HTI, HTI LOW and ECA-II, respectively. The R<sup>2</sup> for TT, STA®-C. K.Prest® and SynthasIL® were 0.67, 0.42 and 0.15. For HTI, HTI LOW and ECA-II, Bland-Altman analyses revealed mean differences of –6 ng/ml (95 %CI: –25–14 ng/ml), 1 ng/ml (95 %CI: –18–19 ng/ml) and –1 ng/ml (95 %CI: –25–23 ng/ml), demonstrating that tests dedicated to measuring low concentrations are more accurate than HTI. In conclusion, the use of HTI LOW or ECA-II to assess low plasma dabigatran concentrations is supported by our findings.
Douxfils, J., 24 oct. 2015
Superviseur: Dogne, J. (Promoteur), Mullier, F. (Promoteur), Masereel, B. (Président), Chatelain, B. (Jury), Chatelain, C. (Personne externe) (Jury), Verhamme, P. (Personne externe) (Jury), TEN CATE, H. (Personne externe) (Jury) & Ageno, W. (Personne externe) (Jury)
Thèse de l'étudiant: Doc types › Docteur en Sciences Biomédicales et Pharmaceutiques
27 oct. 2016
Superviseur: Dogne, J. (Promoteur), Gourdin, M. (Copromoteur), Caron, N. (Président), Masereel, B. (Président), Chatelain, B. (Jury), Ickx, B. E. (Personne externe) (Jury) & Samama, C. (Personne externe) (Jury)
Thèse de l'étudiant: Doc types › Docteur en Sciences Biomédicales et PharmaceutiquesFichier