Abstract
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.
Keywords
coagulometer - point-of-care - anticoagulants - direct oral anticoagulants
