Abstract
Delayed identification of coagulopathy and bleeding increases the risk of organ failure
and death in hospitalized patients. Timely and accurate identification of impaired
coagulation at the point-of-care can proactively identify bleeding risk and guide
resuscitation, resulting in improved outcomes for patients. We test the accuracy of
a novel optical coagulation sensing approach, termed iCoagLab, for comprehensive whole
blood coagulation profiling and investigate its diagnostic accuracy in identifying
patients at elevated bleeding risk. Whole blood samples from patients (N = 270) undergoing conventional coagulation testing were measured using the iCoagLab
device. Recalcified and kaolin-activated blood samples were loaded in disposable cartridges
and time-varying intensity fluctuation of laser speckle patterns were measured to
quantify the clot viscoelastic modulus during coagulation. Coagulation parameters
including the reaction time (R), clot progression time (K), clot progression rate
(α), and maximum clot strength (MA) were derived from clot viscoelasticity traces
and compared with mechanical thromboelastography (TEG). In all patients, a good correlation
between iCoagLab- and TEG-derived parameters was observed (p < 0.001). Multivariate analysis showed that iCoagLab-derived parameters identified
bleeding risk with sensitivity (94%) identical to, and diagnostic accuracy (89%) higher
than TEG (87%). The diagnostic specificity of iCoagLab (77%) was significantly higher
than TEG (69%). By rapidly and comprehensively permitting blood coagulation profiling
the iCoagLab innovation is likely to advance the capability to identify patients with
elevated risk for bleeding, with the ultimate goal of preventing life-threatening
hemorrhage.
Keywords
optical coagulation sensing - whole blood clotting tests - hemorrhage - bleeding -
coagulation
