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In Vitro Thrombosis Test for Ventricular Assist Devices
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Rotation thromboelastometry (ROTEM) stability and reproducibility over time.

Oliver Michel Theusinger1, Johannes Nürnberg, Lars M Asmis

  • 1Institute of Anesthesiology, University Hospital Zurich, CH - 8091 Zurich, Switzerland. oliver.theusinger@usz.ch

European Journal of Cardio-Thoracic Surgery : Official Journal of the European Association for Cardio-Thoracic Surgery
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Summary

Rotation thromboelastography (ROTEM) provides stable blood sample results for up to 120 minutes with minimal variability on a single device. However, slight differences between ROTEM devices were noted, impacting clinical treatment decisions.

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Area of Science:

  • Hematology
  • Clinical Pathology
  • Medical Diagnostics

Background:

  • Thromboelastometry assesses blood clot formation and lysis.
  • Rotation thromboelastography (ROTEM) offers advancements over classic methods.
  • Clinical validation of ROTEM's reproducibility and sample stability is lacking.

Purpose of the Study:

  • To clinically validate ROTEM's reproducibility and sample stability.
  • To assess inter- and intra-assay variability of ROTEM.
  • To determine the effect of storage time on blood sample integrity for ROTEM analysis.

Main Methods:

  • Assessed sample stability over 120 minutes at room temperature in 48 patients.
  • Utilized INTEM, EXTEM, and FIBTEM assays on two ROTEM devices.
  • Evaluated intra- and inter-assay variability in 10 volunteers.
  • Determined reference intervals and effects of age and sex.

Main Results:

  • Blood samples remained stable for 120 minutes with no significant result differences.
  • High precision observed: coefficients of variation <6% for key parameters.
  • Minor but significant differences detected between ROTEM devices for specific assays.

Conclusions:

  • ROTEM provides stable and reproducible results within 120 minutes on a single device.
  • Inter-device variability exists and may be clinically relevant.
  • Consistent use of a single ROTEM device is recommended for critical treatment decisions.