Development of a novel point-of-care device to monitor arterial thrombosis

Abstract

Arterial thrombosis is a leading cause of heart attacks and strokes, representing a significant global health challenge. Microfluidic research studies have identified high shear stress, a thrombotic surface, and the presence of von Willebrand factor (vWF) and platelets as key conditions necessary for formation of arterial thrombi, termed shear-induced platelet aggregation (SIPA). However, current point-of-care (POC) assays of platelet function fail to incorporate these conditions, often relying on artificial agonists alone for stimulation. This study introduces a novel POC device designed to replicate high shear arterial thrombosis to create large platelet-rich clots reliably with small blood samples. The device was tested with blood from 10 healthy donors, with and without treatment with antiplatelet agents ASA, 2MeSAMPS and eptifibatide. The POC endpoint was compared with the PFA-100 to demonstrate novelty. A novel POC was successfully developed that can run with 5 mL of blood, had an intra-patient variability <15% and could distinguish differences in the healthy subjects tested. The POC was sensitive to antiplatelet agents acetyl-salicylic acid, 2-MeSAMPS and eptifibatide, showing an increase in end volume, a proxy for occlusion time, after treatment (p < 0.001). The novel POC device provides a unique endpoint that is uncorrelated with PFA-100 results. The ability of the novel POC to differentiate individual's thrombotic potential underscores its utility for clinical applications such as diagnosing platelet dysfunction, quantifying thrombotic risk, and optimizing antiplatelet therapies. This novel approach bridges the gap between research assays and practical clinical tools, offering a significant advancement in personalized cardiovascular care.