Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients.

Background: Trauma-induced coagulopathy (TIC) occurs in a quarter of trauma patients and is associated with death due to uncontrolled bleeding. Current guidelines recommend viscoelastic testing (VET) to assess coagulopathy and guide transfusions. The Quantra with the QStat Cartridge is a point-of-care (POC) VET device that measures changes in clot stiffness (CS) during coagulation and fibrinolysis using ultrasound detection of resonance. This study aimed to evaluate the performance of the QStat Cartridge in trauma patients compared with rotational thromboelastometry (ROTEM) Methods: A multicenter prospective observational study was conducted in adult patients meeting criteria for a full trauma team response at eight US level 1 trauma centers. Citrated blood samples drawn on arrival at the hospital or after blood transfusions were analyzed in parallel on QStat, ROTEM or TEG. Correlation between QStat and equivalent VET measurements was assessed by linear regression. Concordance was assessed by agreement of results relative to device-specific normal reference ranges. Results: 259 severely injured patients were enrolled, yielding 271 samples for analysis. Moderate to strong correlations between QStat and corresponding ROTEM and TEG measurements were observed (r=0.64-0.88). The concordance between CS results was 84.5% for QStat CS and EXTEM A10 and 83.3% for CS and citrated rapid TEG maximum amplitude. For fibrinogen-related results, concordance was 81.5% for QStat fibrinogen contribution to clot stiffness (FCS) and FIBTEM A10 and 93.8% for FCS and citrated functional fibrinogen maximum amplitude. For fibrinolysis measurements, the overall agreement between QStat clot stability to lysis and EXTEM ML or CK-LY30 was 97.5% and 92.9%, respectively. Conclusion: QStat provides comparable information to the ROTEM Level of evidence: Diagnostic test, level II. Trial registration number: NCT04312958.