Abstract Number: PB0638
Meeting: ISTH 2020 Congress
Background: While use of the non-vitamin K antagonist oral anticoagulants (NOACs) does not currently require routine coagulation monitoring, this can be highly desirable in at-risk patients, including those suffering major trauma or requiring emergency surgery. However, a point-of-care (PoC) device for the rapid, bedside measurement of clotting times in patients on NOACs is currently not available.
Aims: To characterize the sensitivity of Perosphere Technologies’ PoC Coagulometer to NOAC-induced anticoagulation, as well as instrument precision, via two studies: Study 1 – analytical measuring range, and Study 2 – a methods comparison to manual whole blood clotting time (mWBCT).
Methods: These studies were performed using healthy volunteers; for each study, whole blood samples were spiked with either 0 (sham), 30, 75, 150, 300 and 400 (apixaban, edoxaban) or 450 (rivaroxaban) ng/mL of a NOAC, in randomized order. In Study 1, a subject’s divided blood sample was spiked with all concentrations and simultaneously tested on 24 PoC Coagulometers. In Study 2, a single concentration was tested per day, over 6 days, and samples were tested on 5 PoC Coagulometers and by 5 operators performing mWBCT, simultaneously, for comparison.
Results: In Study 1, PoC Coagulometer clotting times exhibited linearity across the measuring range, and sensitivity to even the lowest NOAC concentrations tested, as well as a high level of precision with notably low %CVs (Fig. 1). In Study 2, a strong linear correlation was observed for these methods, with R2 values of nearly 1 (Fig. 2). Across all concentrations, the sensitivity of the PoC Coagulometer was significantly higher when compared to mWBCT, with absolute values of mWBCT measuring roughly twice those of the PoC Coagulometer.
Conclusions: These results suggest that this PoC Coagulometer could be ideal to assess the pharmacodynamic effects of the NOACs. The PoC bedside instrument delivers results within minutes, requiring only a drop of whole blood.
To cite this abstract in AMA style:Bakhru S, Jiang X, Chen L, Wang Y, Osmani D, Mootoo D, Ansell J, Zappe S. Analytical Validation of a Novel Whole Blood Coagulometer for NOAC Testing [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/analytical-validation-of-a-novel-whole-blood-coagulometer-for-noac-testing/. Accessed November 26, 2020.
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