The implementation of a ROTEM® sigma-based algorithm for the management of coagulopathic bleeding in a tertiary center

Abstract

Introduction Viscoelastic assays are used for the management of perioperative or traumatic bleeding (1). Recently, the manufacturer of ROTEM® has introduced the automated sigma model. The change in technology results in new normal ranges and therefore new cutoff values triggering intervention compared to previous published ROTEM®delta cutoff values. Here, we describe the analysis performed to identify new cutoff values and the specific algorithm for the ROTEM®sigma. Methods 78 samples were obtained from 39 patients with various hemostatic defects and 12 healthy volunteers. Chosen standard laboratory test (SLT) cut-offs were fibrinogen (Fi) 37 sec or 1.5x the normal value. PLTEM was calculated as EXTEMA5 – FIBTEMA5. The clinically critical range (CCR) of SLT was defined as the range around the threshold that leads to treatment. Correlation was sought between SLT and ROTEM parameters. The best cut-off for the different ROTEM parameters to identify the chosen SLT thresholds (ROC analysis) were integrated in a step-by-step algorithm (Figure 1). Results Correlation between Fi and FIBTEMA5 was very strong (r = 0.94) but was lower in the CCR (0-2.5 g/l) (r = 0.65). The correlation between Fi and EXTEMA5 was weakly moderate (r = 0.42). PLTEMA5 showed very strong correlation (r = 0.96) with Pltc in the CCR ( Discussion In-house cut-off values of key ROTEM®sigma parameters differ from the published ones for ROTEM®delta. We report the first preliminary ROTEM®sigma-based algorithm for hemorrhage. Diagnostic and therapeutic performances shall be prospectively validated.