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A comparison of the new ROTEM® sigma with its predecessor, the ROTEMdelta
B Schenk1, K Görlinger2,3, B Treml1
1Department of General and Surgical Intensive Care Medicine, Medical University of Innsbruck, Austria.
Anaesthesia
|December 22, 2018
Summary
The ROTEMsigma analyser offers fully automated point-of-care coagulation testing, simplifying bleeding management. This study established its reference ranges and confirmed high accuracy compared to the ROTEMdelta device.
Area of Science:
- Coagulation diagnostics
- Point-of-care testing
- Medical device evaluation
Background:
- Thromboelastometry (TEM) is crucial for managing bleeding disorders.
- Previous TEM systems required manual sample and reagent handling.
- The ROTEMsigma offers a fully automated TEM solution.
Purpose of the Study:
- To establish reference ranges for the ROTEMsigma analyser.
- To compare ROTEMsigma performance against its predecessor, ROTEMdelta.
- To validate the accuracy and precision of the new automated device.
Main Methods:
- Determined ROTEMsigma reference ranges using blood from healthy volunteers.
- Assessed key TEM parameters: CT, A5, and MCF for EXTEM, INTEM, and FIBTEM assays.
- Compared ROTEMsigma results with ROTEMdelta using patient samples (hyper- and hypocoagulable).
Main Results:
- Established reference ranges for ROTEMsigma parameters (e.g., CTEXTEM 48-61s, MCFFIBTEM 5-24mm).
- Demonstrated strong correlations between ROTEMsigma and ROTEMdelta for patient samples (p < 0.001, R > 0.8).
- Showcased high precision for ROTEMsigma performance evaluation (R > 0.99, p < 0.001).
Conclusions:
- The ROTEMsigma analyser provides accurate and precise point-of-care coagulation testing.
- Established reference ranges aid clinical interpretation for the ROTEMsigma.
- The automated system simplifies TEM testing and supports optimized bleeding management.
Keywords:
bleeding managementblood coagulation testsperi-operative managementpoint-of-care testingthromboelastometryMore Related Videos
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