Reference Intervals and Clinical Determinants of Blood Thrombogenicity in Antithrombotic Drug-Naïve Adults Using an Advanced Microchip-Based Device

Abstract Background The Total Thrombus-formation Analysis System 01 (T-TAS 01) is an advanced microchip-based device that enables quantitative assessment of blood thrombogenicity. However, broader clinical implementation remains limited by the lack of well-established reference intervals (RIs) in healthy, antithrombotic drug-naïve individuals. This study aimed to define RIs and identify clinical determinants of blood thrombogenicity in antithrombotic drug-naïve adults using T-TAS 01. Methods Blood thrombogenicity was measured using T-TAS 01 in 319 adults without antithrombotic therapy who underwent health checkups at the Miyakonojo Health Service Center. The T-TAS 01 parameters, PL18-AUC10 and AR10-AUC30, were calculated as the areas under the flow–pressure curves of the PL-chip (type I collagen-coated) and the AR-chip (type I collagen and tissue factor-coated), respectively. Their associations with clinical parameters were assessed using multivariate regression analysis. Results The median age was 46.0 years; 64.3% of participants were female, and 82.1% had no hypertension, dyslipidemia, or diabetes. The median platelet count was 247 × 109/L. The median PL18-AUC10 and AR10-AUC30 values were 392.3 and 1335.9, with RIs of 236.3 to 468.1 and 1010.0 to 1496.2, respectively. PL18-AUC10 was independently associated with white blood cell count (coefficient, 5.15; 95% CI, 0.88–9.41) and platelet count (0.36; 95% CI, 0.25–0.47), whereas AR10-AUC30 was independently associated with body mass index (4.06; 95% CI, 0.06–8.06), platelet count (0.79; 95% CI, 0.52–1.06), and γ-glutamyl transpeptidase (−0.54; 95% CI, −0.90 to −0.18). Conclusions Our findings provide foundational reference data for the clinical application of T-TAS 01 and support its potential as a point-of-care tool for individualized assessment of thrombogenicity.