Diagnostic performance of thromboelastometry in trauma-induced coagulopathy: a comparison between two level I trauma centres using two different devices
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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.
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.
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.
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.
KeywordsTrauma Coagulopathy Thromboelastometry Diagnostic
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.
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).
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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