A comparison of the new ROTEM® sigma with its predecessor, the ROTEMdelta

Abstract

Thromboelastometry point-of-care coagulation testing facilitates optimised management of bleeding. Previous thromboelastometry systems required the blood sample and liquid reagents to be pipetted in several manual steps by trained personnel. The ROTEMsigma coagulation analyser is a fully automated point-of-care device. We aimed to assess the reference ranges of the new device and to compare the results with those of the predecessor device, the ROTEMdelta. We took blood from healthy volunteers and from hyper- or hypocoagulable patients; blood samples from healthy volunteers served to determine reference ranges for the most important parameters for the ROTEMsigma: CT_EXTEM 48-61 s; A5_EXTEM 30-51 mm; MCF_EXTEM 54-70 mm; CT_INTEM 138-174 s; MCF_INTEM 51-67 mm and MCF_FIBTEM 5-24 mm. We then used blood samples from patients to compare the results obtained between the old and the new device. We found a strong correlation between the same tests performed on two ROTEMsigma devices and between the ROTEMsigma and the ROTEMdelta with respect to the determination of thromboelastometry parameters of hyper- and hypocoagulable patients (all p < 0.001 and R > 0.8). Performance evaluation for the ROTEMsigma device showed very high precision (R > 0.99, p < 0.001). Our reference ranges can serve as an important aid for other hospitals using this new device.

Keywords: bleeding management; blood coagulation tests; peri-operative management; point-of-care testing; thromboelastometry.