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Rotation thromboelastometry (ROTEM®) stability and reproducibility over time

Theusinger, Oliver Michel ; Nürnberg, Johannes ; Asmis, Lars M. ; Seifert, Burkhardt ; Spahn, Donat Rudolf

In: European Journal of Cardio-Thoracic Surgery, 2010, vol. 37, no. 3, p. 677-683

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    Titre
    • Rotation thromboelastometry (ROTEM®) stability and reproducibility over time
    Auteur
    • Theusinger, Oliver Michel. Institute of Anesthesiology, University Hospital Zurich, CH - 8091 Zurich, Switzerland
    • Nürnberg, Johannes. Institute of Anesthesiology, University Hospital Zurich, CH - 8091 Zurich, Switzerland
    • Asmis, Lars M.. Clinic of Hematology, University Hospital Zurich, Zurich, Switzerland
    • Seifert, Burkhardt. Biostatistics Unit, Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland
    • Spahn, Donat Rudolf. Institute of Anesthesiology, University Hospital Zurich, CH - 8091 Zurich, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • European Journal of Cardio-Thoracic Surgery, 2010, vol. 37, no. 3, p. 677-683. Elsevier Science B.V.
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:293977
    Summary
    Background: Thromboelastometry is a whole blood assay performed to evaluate the viscoelastic properties during blood clot formation and lysis. Rotation thromboelastography (ROTEM®, Pentapharm GmbH, Munich, Germany) has overcome some of the limitations of classic thromboelastography. So far, no clinical validation on reproducibility (inter- and intra-assay variability) and sample stability over time has been published. Methods: To evaluate the pre-analytic aspects, sample stability over time was assessed in 48 patients in eight age groups. Citrated blood was stored at room temperature. Tests measured every 30min from T 0min up to T 120min on two ROTEM® devices were INTEM (ellagic acid activated intrinsic pathway), EXTEM (tissue factor-triggered extrinsic pathway) and FIBTEM (with platelet inhibitor (cytochalasin D) evaluating the contribution of fibrinogen to clot formation). Precision by intra- and inter-assay variability was evaluated at two points of time in 10 volunteers. Finally, reference intervals and effect of age and sex were evaluated. Results: Blood was stable over 120min and no significant differences in ROTEM® results were found. Maximum clot firmness measurements had a coefficient of variation of ≪3% for EXTEM, ≪5% for INTEM and ≪6% for FIBTEM. For clot formation time, the coefficient of variation was ≪4% for EXTEM and ≪3% for INTEM. Coefficient of variation for angle alpha was ≪3% for EXTEM and ≪6% for INTEM. The coefficient of variation for clotting time was ≪15% for both EXTEM and INTEM. Small but significant differences between ROTEM® devices were found for maximum clot firmness in FIBTEM and INTEM as well as clot formation time and alpha angle in INTEM. Conclusions: ROTEM® yields stable results over 120min with a minimal variability on the same ROTEM® device. However, small but significant differences between ROTEM® devices were observed. Analysis should be performed on the same ROTEM® device if small differences are of importance for treatment