The direct oral
anticoagulants (DOACs) currently require no monitoring for routine
therapy of
atrial fibrillation or
venous thromboembolism. Measurement of activity, however, may be important in patients with major and life-threatening
bleeding, patients needing emergent surgery, in reversal situations, or in patients at high risk of
bleeding or
thrombosis due to underlying conditions. For these patients, a widely available and rapid turnaround assay would be optimal. To date, there is no such assay available, especially for the
direct factor Xa inhibitors. This report describes the performance of a new, rapid turnaround, point-of-care (PoC) assay for measuring the activity of a range of
anticoagulants, including DOACs and heparins, in emergency situations and for routine measurement in high-risk patients. Perosphere Technologies' PoC coagulometer is a handheld instrument that performs individual coagulation tests on samples of fresh whole blood (∼10 µL) with clotting activated by glass contact and endpoint determination performed by infrared spectroscopy. In preclinical studies using rats anticoagulated with therapeutic doses of
edoxaban or
enoxaparin, the PoC coagulometer showed a strong linear correlation between pharmacokinetic parameters and clotting time with
edoxaban (r 2 = 0.994) and with
enoxaparin (r 2 = 0.967). These preclinical results suggest that this PoC coagulometer would be ideal to assess the pharmacodynamic effects of
anticoagulants and their reversal agents. The PoC bedside instrument delivers results within minutes and requires no more than a drop of whole blood. Studies are underway to confirm these results in humans and to further characterize the performance of the instrument.