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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
1   Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland
,
Hugo ten Cate
2   Department of Internal medicine, Laboratory of Clinical Thrombosis and Haemostasis, and Cardiovascular Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands
,
Silvio Kathriner
1   Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland
,
Mattias Casutt
3   Department of Anaesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, Luzerner Kantonsspital, Lucerne, Switzerland
,
Lucas M. Bachmann
4   medignition Inc., Zug, Switzerland
,
Walter A. Wuillemin
1   Division of Haematology and Central Haematology Laboratory, Luzerner Kantonsspital, Lucerne, Switzerland
5   University of Berne, Berne, Switzerland
› Author Affiliations Financial support: This study was supported by the Research Fund Haematology Luzerner Kantonsspital.
Further Information

Publication History

Received: 25 October 2013

Accepted: 26 January 2013

Publication Date:
02 December 2017 (online)

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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

 

  • References

  • 1 Haas T. Point of care diagnostic: thromboelastometry (ROTEM®). Wien Klin Wochenschr 2010; 122 (Suppl. 05) S19-20.
    PubMedSearch in Google Scholar
  • 2 Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol 2005; 27: 81-90.
    CrossrefPubMedSearch in Google Scholar
  • 3 Fenger-Eriksen C, Jensen TM, Kristensen BS. et al. Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. J Thromb Haemost 2009; 07: 795-802.
    CrossrefPubMedSearch in Google Scholar
  • 4 Dick A, Schwaiger M, Jambor C. [Thromboelastography/-metry and external quality control. Results of a pilot study]. Hamostaseologie 2010; 30: 91-95.
    Thieme ConnectPubMedSearch in Google Scholar
  • 5 Rugeri L, Levrat A, David JS. et al. Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost 2007; 05: 289-295.
    CrossrefPubMedSearch in Google Scholar
  • 6 Shore-Lesserson L, Manspeizer HE, DePerio M. et al. Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery. Anesth Analg 1999; 88: 312-319.
    CrossrefPubMedSearch in Google Scholar
  • 7 Girdauskas E, Kempfert J, Kuntze T. et al. Thromboelastometrically guided transfusion protocol during aortic surgery with circulatory arrest: a prospective, randomized trial. J Thorac Cardiovasc Surg 2010; 140: 1117-1124. e2.
    CrossrefPubMedSearch in Google Scholar
  • 8 Fenger-Eriksen C, Tonnesen E, Ingerslev J. et al. Mechanisms of hydroxyethyl starch-induced dilutional coagulopathy. J Thromb Haemost 2009; 07: 1099-1105.
    CrossrefPubMedSearch in Google Scholar
  • 9 Tauber H, Innerhofer P, Breitkopf R. et al. Prevalence and impact of abnormal ROTEM(R) assays in severe blunt trauma: results of the ‘Diagnosis and Treatment of Trauma-Induced Coagulopathy (DIA-TRE-TIC) study’. Br J Anaesth 2011; 107: 378-387.
    CrossrefPubMedSearch in Google Scholar
  • 10 Weber CF, Gorlinger K, Meininger D. et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012; 117: 531-547.
    CrossrefPubMedSearch in Google Scholar
  • 11 Davenport R, Manson J, De’Ath H. et al. Functional definition and characterization of acute traumatic coagulopathy. Crit Care Med 2011; 39: 2652-2658.
    CrossrefPubMedSearch in Google Scholar
  • 12 Rourke C, Curry N, Khan S. et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost 2012; 10: 1342-1351.
    CrossrefPubMedSearch in Google Scholar
  • 13 Schochl H, Cotton B, Inaba K. et al. FIBTEM provides early prediction of massive transfusion in trauma. Crit Care 2011; 15: R265.
    CrossrefPubMedSearch in Google Scholar
  • 14 Kozek-Langenecker SA, Afshari A, Albaladejo P. et al. Management of severe perioperative bleeding: Guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol 2013; 30: 270-382.
    CrossrefPubMedSearch in Google Scholar
  • 15 Spahn DR, Bouillon B, Cerny V. et al. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care 2013; 17: R76.
    CrossrefPubMedSearch in Google Scholar
  • 16 Afshari A, Wikkelso A, Brok J. et al. Thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion. Cochrane Database Syst Rev. 2011 03. CD007871.
    PubMedSearch in Google Scholar
  • 17 Coakley M, Hall JE, Evans C. et al. Assessment of thrombin generation measured before and after cardiopulmonary bypass surgery and its association with postoperative bleeding. J Thromb Haemost 2011; 09: 282-292.
    CrossrefPubMedSearch in Google Scholar
  • 18 Lee GC, Kicza AM, Liu KY. et al. Does rotational thromboelastometry (ROTEM) improve prediction of bleeding after cardiac surgery?. Anesth Analg 2012; 115: 499-506.
    CrossrefPubMedSearch in Google Scholar
  • 19 Wikkelsoe AJ, Afshari A, Wetterslev J. et al. Monitoring patients at risk of massive transfusion with Thrombelastography or Thromboelastometry: a systematic review. Acta Anaesthesiol Scand 2011; 55: 1174-1189.
    CrossrefPubMedSearch in Google Scholar
  • 20 Raza I, Davenport R, Rourke C. et al. The incidence and magnitude of fibrinolytic activation in trauma patients. J Thromb Haemost 2013; 11: 307-314.
    CrossrefPubMedSearch in Google Scholar
  • 21 Callum JL, Rizoli S. Plasma transfusion for patients with severe hemorrhage: what is the evidence?. Transfusion 2012; 52 (Suppl. 01) 30S-37S.
    CrossrefPubMedSearch in Google Scholar
  • 22 Chitlur M, Lusher J. Standardization of thromboelastography: values and challenges. Semin Thromb Hemost 2010; 36: 707-711.
    Thieme ConnectPubMedSearch in Google Scholar
  • 23 Kitchen DP, Kitchen S, Jennings I. et al. Quality assurance and quality control of thrombelastography and rotational Thromboelastometry: the UK NEQAS for blood coagulation experience. Semin Thromb Hemost 2010; 36: 757-763.
    Thieme ConnectPubMedSearch in Google Scholar
  • 24 Price CP. Evidence-based laboratory medicine: supporting decision-making. Clin Chem 2000; 46: 1041-1050.
    CrossrefPubMedSearch in Google Scholar
  • 25 Bruns DE, Huth EJ, Magid E. et al. Toward a checklist for reporting of studies of diagnostic accuracy of medical tests. Clin Chem 2000; 46: 893-895.
    CrossrefPubMedSearch in Google Scholar
  • 26 Chitlur M, Sorensen B, Rivard GE. et al. Standardization of thromboelastography: a report from the TEG-ROTEM working group. Haemophilia 2011; 17: 532-537.
    CrossrefPubMedSearch in Google Scholar
  • 27 Venema LF, Post WJ, Hendriks HG. et al. An assessment of clinical interchange-ability of TEG and RoTEM thromboelastographic variables in cardiac surgical patients. Anesth Analg 2010; 111: 339-344.
    CrossrefPubMedSearch in Google Scholar
  • 28 Sorensen B, Johansen P, Christiansen K. et al. Whole blood coagulation throm-belastographic profiles employing minimal tissue factor activation. J Thromb Haemost 2003; 01: 551-558.
    CrossrefPubMedSearch in Google Scholar
  • 29 Theusinger OM, Nurnberg J, Asmis LM. et al. Rotation thromboelastometry (ROTEM) stability and reproducibility over time. Eur J Cardiothorac Surg 2010; 37: 677-683.
    CrossrefPubMedSearch in Google Scholar
  • 30 Lang T, Bauters A, Braun SL. et al. Multi-centre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis 2005; 16: 301-310.
    CrossrefPubMedSearch in Google Scholar
  • 31 Lang T, von Depka M. Possibilities and limitations of thrombelastometry/-graphy. Hamostaseologie 2006; 26 (03) (Suppl. 01) S20-29.
    Thieme ConnectPubMedSearch in Google Scholar
  • 32 Dargaud Y, Sorensen B, Shima M. et al. Global haemostasis and point of care testing. Haemophilia 2012; 18 (Suppl. 04) 81-88.
    CrossrefPubMedSearch in Google Scholar
  • 33 Kenet G, Stenmo CB, Blemings A. et al. Intra-patient variability of thromboelastographic parameters following in vivo and ex vivo administration of recombinant activated factor VII in haemophilia patients. A multi-centre, randomised trial. Thromb Haemost 2010; 103: 351-359.
    Thieme ConnectPubMedSearch in Google Scholar