218Novel thromboelastography point-of-care test detects all commercially available DOACs at therapeutic concentrations and classifies them as direct thrombin or factor Xa inhibitors with high consistency

Introduction: The increasing use of direct oral anticoagulants (DOAC) calls for a point-of-care test to detect the presence and class of DOACs, especially in emergencies where reversal strategies are required and specific agents are now available. A novel thromboelastography cartridge, in conjunction with the analyser and software including a specific algorithm, detects all commercially available DOACs and distinguishes between anti-factor Xa (AFXa) and direct thrombin inhibitors (DTI). Purpose: To demonstrate the clinical utility of the new DOAC cartridge by establishing that all DOACs can be detected at trough and non-trough blood levels and to demonstrate consistency using repeat measurements. Methods: Following IRB approval, blood was collected from consented subjects at 5 sites in a prospective, open label, observational clinical trial; 190 subjects on DOACs (On-DOAC, apixaban n=54, edoxaban n=4, rivaroxaban n=57 and dabigatran n=75) and 24 subjects not on DOACs (Non-DOAC). An algorithm was established to detect and classify DOACs. Patients were at trough (20–24 hours post rivaroxaban or edoxaban; 9–12 hours post apixaban or dabigatran) or non-trough (<20 hours post rivaroxaban or edoxaban; <9 hours post apixaban or dabigatran). Two replicates were collected for each R measurement. The primary analysis was based on the first replicate. A sensitivity analysis was conducted to ensure the accuracy of randomly selected replicates.