PB0484 - A comparison study of ROTEM® Sigma and ROTEM® Delta in a major tertiary hospital

Background: The ROTEM Sigma is a cartridge based visco-elastic instrument providing global assessment of the coagulation process. It supersedes the ROTEM Delta as a blood management tool to guide targeted component therapy.

Aims: Implementation of a new blood management device in the Transfusion Medicine Unit of a tertiary hospital requires careful assessment of potential differences to ensure continuity of service and consistent patient management.

This study aimed to rule out potential measurement bias resulting from replacement of ROTEM Delta with ROTEM Sigma within the Fiona Stanley Network, and to verify manufacturer reported reference ranges. Study outcomes to be used to address suitability of current transfusion algorithms.

Methods: Blood from 51 healthy donors and 22 control samples manipulated with heparin to mimic a significant cohort of our patient population were run on the Delta and Sigma devices in tandem. Correlation across clinically relevant parameters derived from our ROTEM algorithm for critical bleeding were evaluated. (EXTEM CT +A5, INTEM CT, FIBTEM A5 and HEPTEM CT)

Results: EXTEM, INTEM and HEPTEM CT values displayed modest correlation (0.5, 0.7 and 0.45). Clot firmness at 5 minutes showed good correlation between devices (EXTEM A5 0.89 FIBTEM A5 0.98). A negative bias of 10.0% was recorded on the Sigma FIBTEM A5 (p < 0.00001). Normal ranges derived from this study were in correlation with those reported by Werfen group.

Conclusion(s): Parameters produced by both ROTEM devices used in the Algorithm for Critical Bleeding showed some statistical variation with no clinical significance. Slight bias in FIBTEM A5 unlikely to be reflected in clinical intervention as decision for administration of cryoprecipitate would be made with clinical circumstance and not algorithm alone.
The comparison of these two systems can serve as an aid to other hospitals looking to implement this device.