Comparison of two viscoelastic devices in patients with severe trauma: a prospective observational study

Trauma-induced coagulopathy exacerbates bleeding in severely injured patients, thus worsening clinical outcomes and increasing mortality. Viscoelastic measurement is recommended for trauma induced coagulopathy detection, and the ROTEM® device is routinely used to guide treatment algorithms. ClotPro®, a newer device similar to ROTEM®, has limited evidence supporting its use in patients with trauma. This study aimed to assess agreement and interchangeability between ClotPro® and ROTEM® Delta in severe trauma patients and to evaluate the diagnostic performance of selected viscoelastic parameters against conventional coagulation tests. This prospective, single-arm, observational cohort study was conducted in the emergency department at a level 1 trauma centre. Blood samples from 108 patients with trauma, collected between 2019 and 2021, were analysed with ROTEM® Delta, ClotPro® and standard coagulation tests. Device consistency and agreement for extrinsic and fibrinogen-specific assays were assessed with the intraclass correlation coefficient and Wilcoxon signed-rank test with Spearman correlation for laboratory parameters. For calculation of the optimal cutoff values, ROC analyses were performed, with area under the curve, sensitivity, and specificity calculated. The best cutoff points were selected by maximization of the Youden index. Among patients with a median Injury Severity Score of 29, ROTEM® Delta and ClotPro® showed good reliability for CFT (ICC = 0.787, p < 0.0001) and MCF (ICC = 0.762, p < 0.0001) in extrinsic assays but moderate reliability for A10 (ICC = 0.666, p < 0.0001) and ML (ICC = 0.525, p = 0.0235). Results with both devices demonstrated a moderate correlation with platelet count (ROTEM® Delta: Rs = 0.472, p < 0.0001; ClotPro®: Rs = 0.481, p < 0.0001). Fibrinogen-specific assays correlated strongly with Clauss method fibrinogen levels (FIBTEM MCF Rs = 0.779, p < 0.0001; FIB-test MCF Rs = 0.751, p < 0.0001), although the reliability was poor for MCF (ICC = 0.371, p < 0.0001) between devices. ClotPro® consistently showed higher A10 and MCF values than ROTEM® in fibrinogen-specific assays. In patients with trauma, ROTEM® and ClotPro® parameters showed significant variability; therefore, the two devices cannot be used interchangeably with trauma bleeding management algorithms. A ClotPro® specific algorithm should be established for the management of trauma induced coagulopathy and bleeding.