Determination of reference ranges for the ClotPro® thromboelastometry device in paediatric patients

Abstract

BackgroundA new thromboelastometry analyser (ClotPro®) was developed with advanced diagnostics. The reference ranges of ClotPro® in children ages 0–16 yr have not been reported. MethodsIn this prospective study, venous blood samples from 321 patients were obtained from children undergoing elective surgery after induction of anaesthesia. Reference ranges were defined by calculating the 2.5% and 97.5% percentiles for each age group (0–3 months, 4–12 months, 13–24 months, 2–5 yr, 6–10 yr, and 11–16 yr). ResultsReference ranges of the ClotPro® analyser in all age groups demonstrated significant differences in some parameters between age groups. In the first 3 months of life, a significant shortening of the clotting time (CT) in the extrinsically activated test (EX-test) was observed in children aged 0–3 months compared with children of all older age groups (P<0.001), whereas there were no overall differences in the intrinsically activated test (IN-test). In both assays, the clot amplitude 5 and 10 min after CT (A5, A10 value) was significantly higher in the first year of life compared with children older than 1 yr (EX-test and IN-test A5 and A10, respectively; P<0.001). The strength of fibrin polymerisation (FIB-test) was significantly higher in the first 3 months of life (A5 and A10, P<0.003). ConclusionsClotPro® reference ranges were determined for six paediatric age groups, and show age-dependent differences in specific parameters. These values will be helpful in monitoring haemostasis in paediatric patients and for developing tailored bleeding management protocols. Clinical trial registrationNCT04190615.