A novel whole blood coagulometer for NOAC testing

Abstract

Abstract 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 having to undergo emergency surgery, especially when a NOAC reversal agent is used. However, a point-of-care (PoC) device for the rapid measurement of clotting times in patients on NOACs is currently not available. Purpose To characterize the sensitivity of a novel PoC coagulometer to NOAC-induced anticoagulation, as well as quantify instrument precision, via venous whole blood samples freshly spiked with rivaroxaban, apixaban and edoxaban. Methods This study was conducted using healthy volunteers with normal coagulation lab values, including PT/INR and aPTT, confirmed via laboratory testing. Whole blood samples from two volunteers per NOAC were spiked with either 0 (sham), 75, 150, or 300 ng/mL of rivaroxaban, apixaban or edoxaban, in randomized order, each day for five days of testing. Each day, each spiked sample was run on five PoC coagulometers simultaneously for replicate measurement. Results PoC coagulometer clotting times exhibited a high degree of linearity spanning the measuring range, with R2 values approaching 1, and high sensitivity across NOAC concentrations tested (i.e. each concentration was statistically significantly different from the others), as well as a high level of precision across the five days of testing. Furthermore, the PoC coagulometer yielded notably low %CVs at each concentration tested, for each subject and anticoagulant, ranging from approximately 3–7% (Fig. 1, rivaroxaban and apixaban data from individual subjects shown). Conclusions These results suggest that this PoC coagulometer could be a valuable tool to assess the pharmacodynamic effects of the NOACs in emergency and other settings. The PoC coagulometer yields results within minutes at a patient's bedside, requiring only a drop of whole blood. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Perosphere Technologies Inc.