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Related Experiment Video

Updated: May 12, 2025

Leveraging Turbidity and Thromboelastography for Complementary Clot Characterization
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Comparison of 2 thromboelastography methods using patient and control samples.

Robert Frick1, Brittany Washburn2, Dennis Plocher2

  • 1Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, Missouri, USA.

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|May 8, 2025
PubMed
Summary
This summary is machine-generated.

The ROTEM sigma and delta devices show comparable performance in viscoelastic testing. However, the sigma device exhibited lower extrapolated clinical decision points for specific assays, suggesting potential differences in interpretation for treatment algorithms.

Keywords:
blood product utilizationcoagulationmethod comparisonthromboelastometrytransfusion

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Area of Science:

  • Hemostasis and thrombosis research
  • Point-of-care diagnostics
  • Medical device comparison

Background:

  • Point-of-care viscoelastic testing aids in reducing blood loss and transfusions.
  • The ROTEM sigma, a cartridge-based system, aims to enhance point-of-care use.
  • Limited studies compare the ROTEM sigma with the established ROTEM delta.

Purpose of the Study:

  • To compare the performance of the ROTEM sigma system against the ROTEM delta.
  • To assess the comparability of results obtained from both ROTEM devices.

Main Methods:

  • Method comparison study using ROTEM delta as the predicate.
  • Blood samples from healthy donors and surgical patients (liver transplant, obstetrics, cardiovascular, trauma) were analyzed.
  • Imprecision and manufacturer reference intervals were evaluated for both devices.

Main Results:

  • High correlation (Pearson r > .85) between ROTEM delta and sigma for most parameters.
  • Slightly lower correlation for FIBTEM A10, FIBTEM A20, and EXTEM clotting time.
  • Comparable reference intervals and no significant difference in delta-guided algorithm thresholds.
  • Observed negative bias in sigma's extrapolated A5 parameters for EXTEM and FIBTEM.

Conclusions:

  • ROTEM delta and sigma demonstrate comparable overall performance.
  • The sigma system shows a negative bias in specific assays (FIBTEM, EXTEM A5), impacting clinical decision points.
  • Potential differences in extrapolated values necessitate careful consideration when applying delta-guided algorithms to sigma data.