Background: Thromboelastometry (ROTEM), as a point of care test, is an attractive tool for rapid evaluation of hemostasis. Currently, no reference ranges exist for all ROTEM assays in neonates, limiting its use in this vulnerable population. The aim of the present study was: (1) to establish reference ranges for standard extrinsically activated (EXTEM), intrinsically activated (INTEM), and fibrinogen polymerization (FIBTEM) ROTEM assays in whole blood samples of healthy term neonates; (2) to determine the impact of gender, delivery mode, and hematocrit on ROTEM parameters.
Methods: EXTEM, INTEM, and FIBTEM ROTEM assays were performed simultaneously with complete blood count in 215 healthy term neonates.
Results: Reference ranges (2.5th and 97.5th percentiles) were obtained for clotting time (CT), clot formation time (CFT), α-angle, clot firmness at 10 min (A10), maximum clot firmness (MCF), and lysis index at 60 min (LI60, %). Reference ranges for EXTEM were CT 38-78 s, CFT 49-148 s, A10 40-65 mm, and MCF 47-69 mm, LI60 83-98%. For INTEM, CT 134-270 s, CFT 50-142 s, A10 41-63 mm, and MCF 48-67 mm, LI60 85-97%, and finally, for FIBTEM: CT 36-85 s, A10 9-25 mm and MCF 10-26 mm, LI60 92-100%. Hematocrit values were positively correlated with CT, CFT and negatively with A10, MCF values.
Conclusion: This study provides, for the first time, reference ranges for ROTEM EXTEM/INTEM/FIBTEM values simultaneously in healthy term neonates. The combined evaluation of ROTEM tests increases its diagnostic accuracy, contributing to the expansion of ROTEM use in the neonatal population.
Keywords: healthy term neonates; neonatal hemostasis; reference range; thromboelastometry; transfusion-guided therapy.