Thrombelastography detects dabigatran at therapeutic concentrations in vitro to the same extent as gold-standard tests

TY - JOUR

T1 - Thrombelastography detects dabigatran at therapeutic concentrations in vitro to the same extent as gold-standard tests

AU - Solbeck, Sacha

AU - Ostrowski, Sisse R

AU - Stensballe, Jakob

AU - Johansson, Pär I

N1 - Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

PY - 2016/4/1

Y1 - 2016/4/1

N2 - Background/objectives Dabigatran is an oral anticoagulant approved for treatment of non-valvular atrial fibrillation, deep venous thrombosis (DVT), pulmonary embolism and prevention of DVT following orthopedic surgery. Monitoring of the dabigatran level is essential in trauma and bleeding patients but the available plasma-based assays may not sufficiently display its hemostatic effect. This study investigated the in vitro effect of different concentrations of dabigatran on whole blood thrombelastography (TEG) and its correlation to the specific but time-consuming plasma-based tests Hemoclot and Ecarin Clotting Time (ECT). Method Blood was collected from 8 healthy donors (two females, six males) with a median age of 46 years and it was spiked with dabigatran to a range of plasma concentrations (0, 50, 100, 200 and 400 ng/ml) covering the therapeutic level. Results Mean TEG R at 0 ng/ml = 5.963 min, 50 ng/ml = 7.425 min, 100 ng/ml = 8.425 min, 200 ng/ml = 9.775 min, 400 ng/ml = 11.813 min. A significant overall increase (p = 0.001) in TEG reaction time (R) was found across increasing dabigatran concentrations i.e. 0 vs 50 vs 100 vs 200 vs 400 ng/ml (p < 0.000 p = 0.027 p = 0.026, p = 0.005, respectively). TEG R correlated strongly with Hemoclot (R2 = 0.891, p < 0000) and ECT (R2 = 0.914, p < 0.000) and Hemoclot and ECT were strongly inter-correlated (R2 = 0.978, p < 0.000). Conclusion The whole blood viscoelastic assay TEG R displayed linearity towards fixed concentrations of dabigatran and correlated strongly to the current gold-standard tests Hemoclot and ECT, for assessing dabigatran. TEG R is applicable as a rapid and precise whole blood monitoring test for dabigatran treated patients in the emergency setting.

AB - Background/objectives Dabigatran is an oral anticoagulant approved for treatment of non-valvular atrial fibrillation, deep venous thrombosis (DVT), pulmonary embolism and prevention of DVT following orthopedic surgery. Monitoring of the dabigatran level is essential in trauma and bleeding patients but the available plasma-based assays may not sufficiently display its hemostatic effect. This study investigated the in vitro effect of different concentrations of dabigatran on whole blood thrombelastography (TEG) and its correlation to the specific but time-consuming plasma-based tests Hemoclot and Ecarin Clotting Time (ECT). Method Blood was collected from 8 healthy donors (two females, six males) with a median age of 46 years and it was spiked with dabigatran to a range of plasma concentrations (0, 50, 100, 200 and 400 ng/ml) covering the therapeutic level. Results Mean TEG R at 0 ng/ml = 5.963 min, 50 ng/ml = 7.425 min, 100 ng/ml = 8.425 min, 200 ng/ml = 9.775 min, 400 ng/ml = 11.813 min. A significant overall increase (p = 0.001) in TEG reaction time (R) was found across increasing dabigatran concentrations i.e. 0 vs 50 vs 100 vs 200 vs 400 ng/ml (p < 0.000 p = 0.027 p = 0.026, p = 0.005, respectively). TEG R correlated strongly with Hemoclot (R2 = 0.891, p < 0000) and ECT (R2 = 0.914, p < 0.000) and Hemoclot and ECT were strongly inter-correlated (R2 = 0.978, p < 0.000). Conclusion The whole blood viscoelastic assay TEG R displayed linearity towards fixed concentrations of dabigatran and correlated strongly to the current gold-standard tests Hemoclot and ECT, for assessing dabigatran. TEG R is applicable as a rapid and precise whole blood monitoring test for dabigatran treated patients in the emergency setting.

KW - Adult

KW - Antithrombins

KW - Blood Coagulation

KW - Cardiovascular Diseases

KW - Dabigatran

KW - Drug Monitoring

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Reference Standards

KW - Thrombelastography

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.ijcard.2016.01.148

DO - 10.1016/j.ijcard.2016.01.148

M3 - Journal article

C2 - 26826624

SN - 0167-5273

VL - 208

SP - 14

EP - 18

JO - International Journal of Cardiology

JF - International Journal of Cardiology

ER -