Advertisement

Diagnostic performance of thromboelastometry in trauma-induced coagulopathy: a comparison between two level I trauma centres using two different devices

  • Pierre BouzatEmail author
  • Romain Guerin
  • Bastien Boussat
  • Jérôme Nicolas
  • Aline Lambert
  • Jules Greze
  • Marc Maegele
  • Jean-Stéphane David
Original Article
  • 49 Downloads

Abstract

Purpose

The implementation of a ROTEM®-based algorithm requires reliable thresholds to mirror a prothrombin time (PT) ratio > 1.2 and/or a fibrinogen concentration < 1.5 g l−1. Our goal was to compare the diagnostic performances of two devices (ROTEM® Sigma and Delta, IL Werfen, Munich, Germany) in two level-I trauma centres for the diagnostic of post-traumatic coagulopathy.

Methods

We conducted a retrospective analysis of two registries across two periods of time: from September 2014 to December 2015 in Lyon-Sud university trauma centre and from April 2016 to January 2018 in the Grenoble Alps Trauma Centre. Accuracies of EXTEM and FIBTEM assays to detect patients with coagulation disorders were tested for each device using receiver operating characteristic (ROC) analyses.

Results

Within the study period, 74 trauma patients in the Grenoble cohort and 75 trauma patients in the Lyon cohort had concomitant ROTEM® and standard coagulation testing on admission. No statistically significant difference was found between the two ROC curves for FIBTEM amplitude at 5 min (A5), FIBTEM maximum clot firmness, EXTEM clotting time (CT) and EXTEM A5 for ROTEM® Sigma and Delta to diagnose post-traumatic coagulation disorders. The best threshold for FIBTEM A5 to predict low fibrinogen concentration was 7 mm for each device. EXTEM CT thresholds to diagnose PT ratio > 1.2 were 78 s and 74 s for ROTEM® Sigma and Delta, respectively.

Conclusions

These results suggest that ROTEM®-based algorithms may be transposed from one trauma centre to another independently of the setting and the ROTEM® device in use.

Keywords

Trauma Coagulopathy Thromboelastometry Diagnostic 

Notes

Author contributions

PB, RG, JN, AL, JG and JSD conceived the study and designed the trial. PB, RG, JN, AL, JG and JSD supervised data collection. PB, JSD and BB managed the data. BB provided statistical advice on study design and analyzed the data. PB, BB, MM and JSD drafted the manuscript, and all authors contributed substantially to its revision. PB takes responsibility for the paper as a whole.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors

Compliance with ethical standards

Conflict of interest

PB received grants from LFB Biomedicaments. JSD received honoraria, congress travel support and fees for serving speaker from LFB Biomedicaments. Marc Maegele has received honoraria, congress travel support and fees for serving speaker and advisory boards from Astra Zeneca, Bayer, Biotest, CSL Behring, TEM International, IL Werfen and LFB Biomedicaments

Ethics approval and consent to participate

The Regional Institutional Ethics Committee (Comité d’Ethique des Centres d’Investigation Clinique de l’inter-région Rhône-Alpes-Auvergne, IRB number 5891) approved the implementation of the TRENAU registry (File number: 2013-07, approved on March 27, 2013) and, given its observational nature, waived the requirements for written informed consent from each patient. The RESUVAL registry, which is supervised by the regional network RESUVAL, was approved by the national data protection commission (Commission Nationale Informatique et Liberté, N°2009-674).

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

References

  1. 1.
    Frith D, Goslings JC, Gaarder C, Maegele M, Cohen MJ, Allard S, et al. Definition and drivers of acute traumatic coagulopathy: clinical and experimental investigations. J Thromb Haemost. 2010;8:1919–25.CrossRefGoogle Scholar
  2. 2.
    Khan S, Davenport R, Raza I, Glasgow S, De’Ath HD, Johansson PI, et al. Damage control resuscitation using blood component therapy in standard doses has a limited effect on coagulopathy during trauma hemorrhage. Intensive Care Med. 2015;41:239–47.CrossRefGoogle Scholar
  3. 3.
    MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003;55:39–44.CrossRefGoogle Scholar
  4. 4.
    Maegele M, Lefering R, Yucel N, Tjardes T, Rixen D, Paffrath T, et al. Early coagulopathy in multiple injury: an analysis from the German Trauma Registry on 8724 patients. Injury. 2007;38:298–304.CrossRefGoogle Scholar
  5. 5.
    Hess JR, Brohi K, Dutton RP, Hauser CJ, Holcomb JB, Kluger Y, et al. The coagulopathy of trauma: a review of mechanisms. J Trauma. 2008;65:748–54.CrossRefGoogle Scholar
  6. 6.
    Maegele M, Schochl H, Cohen MJ. An update on the coagulopathy of trauma. Shock. 2014;41(Suppl 1):21–5.CrossRefGoogle Scholar
  7. 7.
    Dzik WH. Predicting hemorrhage using preoperative coagulation screening assays. Curr Hematol Rep. 2004;3:324–30.Google Scholar
  8. 8.
    Davenport R, Manson J, De’Ath H, Platton S, Coates A, Allard S, et al. Functional definition and characterization of acute traumatic coagulopathy. Crit Care Med. 2011;39:2652–8.CrossRefGoogle Scholar
  9. 9.
    Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005;27:81–90.CrossRefGoogle Scholar
  10. 10.
    Brenni M, Worn M, Bruesch M, Spahn DR, Ganter MT. Successful rotational thromboelastometry-guided treatment of traumatic haemorrhage, hyperfibrinolysis and coagulopathy. Acta Anaesthesiol Scand. 2010;54:111–7.CrossRefGoogle Scholar
  11. 11.
    Doran CM, Woolley T, Midwinter MJ. Feasibility of using rotational thromboelastometry to assess coagulation status of combat casualties in a deployed setting. J Trauma. 2010;69(Suppl 1):S40–8.CrossRefGoogle Scholar
  12. 12.
    Schochl H, Cotton B, Inaba K, Nienaber U, Fischer H, Voelckel W, et al. FIBTEM provides early prediction of massive transfusion in trauma. Crit Care. 2011;15:R265.CrossRefGoogle Scholar
  13. 13.
    Schochl H, Nienaber U, Hofer G, Voelckel W, Jambor C, Scharbert G, et al. Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM)-guided administration of fibrinogen concentrate and prothrombin complex concentrate. Crit Care. 2010;14:R55.CrossRefGoogle Scholar
  14. 14.
    Schochl H, Nienaber U, Maegele M, Hochleitner G, Primavesi F, Steitz B, et al. Transfusion in trauma: thromboelastometry-guided coagulation factor concentrate-based therapy versus standard fresh frozen plasma-based therapy. Crit Care. 2011;15:R83.CrossRefGoogle Scholar
  15. 15.
    Veigas PV, Callum J, Rizoli S, Nascimento B, da Luz LT. A systematic review on the rotational thrombelastometry (ROTEM(R)) values for the diagnosis of coagulopathy, prediction and guidance of blood transfusion and prediction of mortality in trauma patients. Scand J Trauma Resusc Emerg Med. 2016;24:114.CrossRefGoogle Scholar
  16. 16.
    Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, et al. The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition. Crit Care. 2016;20:100.CrossRefGoogle Scholar
  17. 17.
    Inaba K, Rizoli S, Veigas PV, Callum J, Davenport R, Hess J, et al. 2014 Consensus conference on viscoelastic test-based transfusion guidelines for early trauma resuscitation: report of the panel. J Trauma Acute Care Surg. 2015;78:1220–9.CrossRefGoogle Scholar
  18. 18.
    Brohi K, Cohen MJ, Davenport RA. Acute coagulopathy of trauma: mechanism, identification and effect. Curr Opin Crit Care. 2007;13:680–5.CrossRefGoogle Scholar
  19. 19.
    Yuan S, Ferrell C, Chandler WL. Comparing the prothrombin time INR versus the APTT to evaluate the coagulopathy of acute trauma. Thromb Res. 2007;120:29–37.CrossRefGoogle Scholar
  20. 20.
    Rugeri L, Levrat A, David JS, Delecroix E, Floccard B, Gros A, et al. Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost. 2007;5:289–95.CrossRefGoogle Scholar
  21. 21.
    Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, et al. Goal-directed hemostatic resuscitation of trauma-induced coagulopathy: a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays. Ann Surg. 2016;263:1051–9.CrossRefGoogle Scholar
  22. 22.
    Levy JH, Welsby I, Goodnough LT. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion. 2014;54:1389–405 (quiz 8).CrossRefGoogle Scholar
  23. 23.
    Bouzat P, Ageron FX, Charbit J, Bobbia X, Deras P, Nugues JBD, et al. Modelling the association between fibrinogen concentration on admission and mortality in patients with massive transfusion after severe trauma: an analysis of a large regional database. Scand J Trauma Resusc Emerg Med. 2018;26:55.CrossRefGoogle Scholar
  24. 24.
    Erdoes G, Gerster G, Colucci G, Kaiser H, Alberio L, Eberle B. Prediction of post-weaning fibrinogen status during cardiopulmonary bypass: an observational study in 110 patients. PLoS One. 2015;10:e0126692.CrossRefGoogle Scholar
  25. 25.
    Herbstreit F, Winter EM, Peters J, Hartmann M. Monitoring of haemostasis in liver transplantation: comparison of laboratory based and point of care tests. Anaesthesia. 2010;65:44–9.CrossRefGoogle Scholar
  26. 26.
    Mace H, Lightfoot N, McCluskey S, Selby R, Roy D, Timoumi T, et al. Validity of thromboelastometry for rapid assessment of fibrinogen levels in heparinized samples during cardiac surgery: a retrospective, single-center, observational study. J Cardiothorac Vasc Anesth. 2016;30:90–5.CrossRefGoogle Scholar
  27. 27.
    Ogawa S, Szlam F, Bolliger D, Nishimura T, Chen EP, Tanaka KA. The impact of hematocrit on fibrin clot formation assessed by rotational thromboelastometry. Anesth Analg. 2012;115:16–21.CrossRefGoogle Scholar
  28. 28.
    Song JG, Jeong SM, Jun IG, Lee HM, Hwang GS. Five-minute parameter of thromboelastometry is sufficient to detect thrombocytopenia and hypofibrinogenaemia in patients undergoing liver transplantation. Br J Anaesth. 2014;112:290–7.CrossRefGoogle Scholar
  29. 29.
    Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012;10:1342–51.CrossRefGoogle Scholar
  30. 30.
    Innerhofer P, Fries D, Mittermayr M, Innerhofer N, von Langen D, Hell T, et al. Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial. Lancet Haematol. 2017;4:e258–71.CrossRefGoogle Scholar
  31. 31.
    Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, et al. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015;19:97.CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Pierre Bouzat
    • 1
    • 2
    • 8
    Email author
  • Romain Guerin
    • 1
  • Bastien Boussat
    • 2
    • 3
    • 4
  • Jérôme Nicolas
    • 5
  • Aline Lambert
    • 5
  • Jules Greze
    • 1
  • Marc Maegele
    • 6
  • Jean-Stéphane David
    • 5
    • 7
  1. 1.Department of Anaesthesiology and Intensive Care Medicine, Grenoble Alps Trauma CentreGrenoble University HospitalGrenobleFrance
  2. 2.Grenoble Alps UniversityGrenobleFrance
  3. 3.Quality of Care UnitGrenoble University HospitalGrenobleFrance
  4. 4.Department of Community Health Sciences, Cumming School of MedicineUniversity of CalgaryCalgaryCanada
  5. 5.Charles Mérieux–Lyon Sud School of Medicine, University Lyon 1OullinsFrance
  6. 6.Department of Traumatology and Orthopaedic Surgery, Cologne-Merheim Medical Center, Institue for Research in Operative MedicineUniversity Witten-HerdeckeCologneGermany
  7. 7.Department of Anaesthesiology and Critical Care MedicineLyon-Sud Hospital, Hospices Civils de LyonPierre BéniteFrance
  8. 8.Pôle d’Anesthésie-Réanimation, Hôpital Albert MichallonGrenobleFrance

Personalised recommendations