Consistency of thromboelastometry analysis under scrutiny: Results of a systematic evaluation within and between analysers

Michael Nagler; Hugo ten Cate; Silvio Kathriner; Mattias Casutt; Lucas M. Bachmann; Walter A. Wuillemin

doi:10.1160/TH13-10-0870

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2014; 111(06): 1161-1166
DOI: 10.1160/TH13-10-0870

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Consistency of thromboelastometry analysis under scrutiny: Results of a systematic evaluation within and between analysers

Michael Nagler

¹Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland

,

Hugo ten Cate

²Department of Internal medicine, Laboratory of Clinical Thrombosis and Haemostasis, and Cardiovascular Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands

,

Silvio Kathriner

¹Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland

,

Mattias Casutt

³Department of Anaesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, Luzerner Kantonsspital, Lucerne, Switzerland

,

Lucas M. Bachmann

⁴medignition Inc., Zug, Switzerland

,

Walter A. Wuillemin

¹Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland

⁵University of Berne, Berne, Switzerland

› Institutsangaben

Abstract

Summary

While the use of thromboelastometry analysis (ROTEM^®) in evaluation of haemostasis is rapidly increasing, important validity parameters of testing remain inadequately examined. We aimed to study systematically the consistency of thromboelastometry parameters within individual tests regarding measurements between different analysers, between different channels of the same analyser, between morning and afternoon measurements (circadian variation), and if measured four weeks apart. Citrated whole blood samples from 40 healthy volunteers were analysed with two analysers in parallel. EXTEM, INTEM, FIBTEM, HEPTEM and APTEM tests were conducted. A Bland-Altman comparison was performed and homogeneity of variances was tested using the pitman test. P-value ranges were used to classify the level of homogeneity (p<0.15 – low homogeneity, p = 0.15 to 0.5 – intermediate homogeneity, p>0.5 high homogeneity). Less than half of all comparisons made showed high homogeneity of variances (p>0.5) and in about a fifth of comparisons data distributions were heterogeneous (p<0.15). There was no clear pattern for homogeneity. On average, comparisons of MCF, ML and LI30 measurements tended to be better, but none of the tests assessed outperformed another. In conclusion, systematic investigation reveals large differences in the results of some thromboelastometry parameters and lack of consistency. Clinicians and scientists should take these inconsistencies into account and focus on parameters with a higher homogeneity such as MCF.

Note: Part of the investigation was presented at the 56th meeting of the “Gesellschaft für Thrombose- und Hämostaseforschung (GTH)” in St. Gallen, Switzerland, February 1–4, 2012.

Keywords

Thromboelastometry - reliability - reproducibility

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Referenzen

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