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Data-driven Development of ROTEM and TEG Algorithms for the Management of Trauma Hemorrhage

A Prospective Observational Multicenter Study

Baksaas-Aasen, Kjersti MD*; Van Dieren, Susan PhD; Balvers, Kirsten PhD; Juffermans, Nicole P. PhD; Næss, Pål A. PhD*; Rourke, Claire BSc§; Eaglestone, Simon PhD§; Ostrowski, Sisse R. PhD; Stensballe, Jakob PhD||; Stanworth, Simon PhD**; Maegele, Marc PhD††; Goslings, Carel PhD; Johansson, Pär I. PhD; Brohi, Karim MD§; Gaarder, Christine PhD§§ the TACTIC/INTRN collaborators

doi: 10.1097/SLA.0000000000002825
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Objective: Developing pragmatic data-driven algorithms for management of trauma induced coagulopathy (TIC) during trauma hemorrhage for viscoelastic hemostatic assays (VHAs).

Background: Admission data from conventional coagulation tests (CCT), rotational thrombelastometry (ROTEM) and thrombelastography (TEG) were collected prospectively at 6 European trauma centers during 2008 to 2013.

Methods: To identify significant VHA parameters capable of detecting TIC (defined as INR > 1.2), hypofibrinogenemia (< 2.0 g/L), and thrombocytopenia (< 100 x109/L), univariate regression models were constructed. Area under the curve (AUC) was calculated, and threshold values for TEG and ROTEM parameters with 70% sensitivity were included in the algorithms.

Results: A total of, 2287 adult trauma patients (ROTEM: 2019 and TEG: 968) were enrolled. FIBTEM clot amplitude at 5 minutes (CA5) had the largest AUC and 10 mm detected hypofibrinogenemia with 70% sensitivity. The corresponding value for functional fibrinogen (FF) TEG maximum amplitude (MA) was 19 mm. Thrombocytopenia was similarly detected using the calculated threshold EXTEM-FIBTEM CA5 30 mm. The corresponding rTEG-FF TEG MA was 46 mm. TIC was identified by EXTEM CA5 41 mm, rTEG MA 64 mm (80% sensitivity). For hyperfibrinolysis, we examined the relationship between viscoelastic lysis parameters and clinical outcomes, with resulting threshold values of 85% for EXTEM Li30 and 10% for rTEG Ly30.

Based on these analyses, we constructed algorithms for ROTEM, TEG, and CCTs to be used in addition to ratio driven transfusion and tranexamic acid.

Conclusions: We describe a systematic approach to define threshold parameters for ROTEM and TEG. These parameters were incorporated into algorithms to support data-driven adjustments of resuscitation with therapeutics, to optimize damage control resuscitation practice in trauma.

*Department of Traumatology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway

Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands

Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, the Netherlands

§Center for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, United Kingdom

Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

||Department of Anesthesiology, Center of Head and Orthopedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

**NHS Blood and Transplant, Oxford University Hospital NHS Trust, John Radcliffe Hospital, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom

††Department for Traumatology and Orthopedic Surgery, Cologne- Merheim Medical Center, University of Witten/Herdecke, Cologne, Germany

§§Department of Traumatology, Oslo University Hospital, Oslo, Norway.

Reprints: Christine Gaarder, PhD, Department of Traumatology, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424 Oslo, Norway. E-mail: tinagaar@online.no.

Disclosure: This study is part-funded by the European Commission under the FP-7 HEALTH-Contract No. F3–2013–602771, entitled “Targeted Action for Curing Trauma Induced Coagulopathy” (TACTIC).

Website European Commission FP-7 HEALTH-Contract No. F3–2013–602771: http://cordis.europa.eu/project/rcn/110071_en.html.

Both TEM International GmbH and Haemonetics are equal partners in the TACTIC program, and have been providing VHA devices and reagents for all participating institutions.

TACTIC/INTRN collaborators: R. Bergman, H. Campbell, N. Curry, E.K. Stürmer, N. Schäfer, A. Driessen, A. Orr, K. Görlinger, N. Flåten, and K.M. Kolstadbraaten. The authors declare no conflict of interests.

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