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

Bouzat, Pierre; Guerin, Romain; Boussat, Bastien; Nicolas, Jean‐François; Lambert, Aline; Grèze, Jules; Maegele, Marc; David, Jean-Stéphane

doi:10.1007/s00068-019-01165-7

Cited by 17 publications

(13 citation statements)

References 28 publications

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“…Multiple studies have looked at optimal threshold values of the early FIBTEM parameters A5 and A10 to quickly determine if fibrinogen levels are below a critical point. One study found a similar threshold for A5 as we did (9.5 mm) to determine fibrinogen levels below 1.5 g/L in trauma patients [15], while other studies determined lower threshold levels (5, 6 or 7 mm) [12,20,22,23]. For A10, only one study in patients undergoing cardiac surgery determined the optimal cut-off value, which was similar to ours [24].…”

Section: Discussionsupporting

confidence: 81%

FIBTEM clot firmness parameters correlate well with the fibrinogen concentration measured by the Clauss assay in patients and healthy subjects

Vries

Veen

Snoek

et al. 2020

Scandinavian Journal of Clinical and Laboratory Investigation

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The Clauss assay is the assay most often used for measuring plasma fibrinogen levels. However, the FIBTEM-assay, determined using thromboelastometry (ROTEM) can also be used to estimate fibrinogen levels. A major advantage of the FIBTEM is that it can provide information about fibrinogen levels within minutes, while the Clauss assay needs 30-60 min before the result is available. The aim of this study was to investigate the correlation between fibrinogen levels measured by the Clauss assay and results from the FIBTEM-assay. We included 111 patients 18 years for whom both ROTEM analyses and a fibrinogen measurement using the Clauss assay were available. In addition, ROTEM and Clauss measurements from 75 healthy subjects were included. Spearman correlation was used to determine the association between the results of both assays. The patients included were mostly patients with major trauma or undergoing large surgery (e.g. cardiac surgery or liver transplantation). Strong correlations were found between FIBTEM clot firmness parameters and fibrinogen levels measured by the Clauss assay in patients (Spearman's correlation coefficients (r s) above 0.80 (p < .001) for all subgroups) and healthy subjects (r s ¼ 0.66, p < .001). The correlation between early FIBTEM parameters (clot firmness at 5 or 10 min) and the maximum clot firmness was almost perfect (r s above 0.96). Also, the correlation between the a-angle and FIBTEM parameters was strong (r s above 0.7). In conclusion, strong correlations were found between early FIBTEM parameters and fibrinogen levels.

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Section: Discussionsupporting

confidence: 81%

FIBTEM clot firmness parameters correlate well with the fibrinogen concentration measured by the Clauss assay in patients and healthy subjects

Vries

Veen

Snoek

et al. 2020

Scandinavian Journal of Clinical and Laboratory Investigation

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“…reported the diagnostic performance of thromboelastometry in trauma-induced coagulopathy in two separate trauma centres, one of which used the ROTEMdelta, and the other the ROTEMsigma. 27 The centre using the ROTEMdelta found that an A5 ≤6 mm had 85% sensitivity and 90% specificity for the identification of fibrinogen <1.5 g/l, which was similar to the other centre using a ROTEMsigma (sensitivity 83%, specificity 82%). They concluded that the same ROTEM-based algorithms for trauma-induced coagulopathy could be used for either device.…”

Section: Discussionsupporting

confidence: 57%

An audit of the diagnostic accuracy of the ROTEM®sigma for the identification of hypofibrinogenaemia in cardiac surgical patients

Matzelle

Preuss

Weightman

et al. 2022

Anaesth Intensive Care

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The ROTEM®delta (TEM Innovations GmbH, Munich, Germany) has been used extensively worldwide for the assessment of coagulation in cardiac surgical patients. Recently, a new cartridge-based ROTEM device (ROTEM®sigma, TEM Innovations GmbH, Munich, Germany) has become available. In this paper we report an audit of the diagnostic accuracy of the ROTEM sigma for the identification of hypofibrinogenaemia in cardiac surgical patients. We hypothesised that the diagnostic accuracy of the ROTEMsigma for the identification of hypofibrinogenaemia would be in a similar range to that previously reported for the ROTEMdelta. Simultaneous blood samples for Clauss laboratory fibrinogen and ROTEMsigma FIBTEM measurements were obtained immediately after heparin reversal post-cardiopulmonary bypass in 200 adult cardiac surgical patients. The sensitivity, specificity, and positive and negative predictive values for FIBTEM A5 and A10 for the identification of hypofibrinogenaemia (Clauss fibrinogen <1.5 g/l) were calculated. The prevalence of hypofibrinogenaemia across the 200 patients was 8%. The mean sensitivity and specificity of FIBTEM A10 ≤8 mm for the identification of hypofibrinogenaemia were 0.75 and 0.90 respectively, which are in a similar range to that reported in several previous studies using the ROTEMdelta. For FIBTEM A5 ≤6 mm the values were 0.63 and 0.98 respectively. The predictive values were also in a similar range to those previously reported for the ROTEMdelta, with low false negative rates (2% for A10 ≤8 mm; 3% for A5 ≤6 mm). These findings support the use of the ROTEMsigma as an alternative to the ROTEMdelta for the identification of hypofibrinogenaemia post-cardiopulmonary bypass in cardiac surgical patients. However, further studies are required in other settings.

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“…The latest version of either the ROTEM (RoTem Sigma (WERFEN) or the TEG device (TEG6 Haemonetics) will be used in the present study. Indeed, these new versions are associated with greater ease of use and the measured parameters closely correlate with those obtained from their predecessor 22–24. The choice of either the RoTem Sigma or the TEG6 Haemonetics has been left to the discretion of each participating centre before the beginning of the study.…”

Section: Methods and Analysismentioning

confidence: 99%

Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study)

et al. 2019

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IntroductionDuring cardiac surgery-associated bleeding, the early detection of coagulopathy is crucial. However, owing to time constraints or lack of suitable laboratory tests, transfusion of haemostatic products is often inappropriately triggered, either too late (exposing to prolonged bleeding and thus to avoidable administration of blood products) or blindly to the coagulation status (exposing to unnecessary haemostatic products administration in patients with no coagulopathy). Undue exposition to transfusion risks and additional healthcare costs may arise. With the perspective of secondary care-related costs, the IMOTEC study (Intérêt MédicO-économique de la Thrombo-Elastographie, dans le management transfusionnel des hémorragies péri-opératoires de chirurgies Cardiaques sous circulation extracorporelle) aims at assessing the cost-effectiveness of a point-of-care viscoelastic haemostatic assay (VHA: RoTem or TEG)-guided management of bleeding. Among several outcome measures, particular emphasis will be put on quality of life with a 1-year follow-up.Methods and analysisThis is a multicentre, prospective, pragmatic study with stepped-wedge cluster randomised controlled design. Over a 36-month period (24 months of enrolment and 12 months of follow-up), 1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass will be included if a periprocedural significant bleeding occurs. The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients’ quality of life. Secondary outcomes are the cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality.Ethics and disseminationThe study was registered at Clinicaltrials.gov and was approved by the Committee for the Protection of Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority. A publication of the results in a peer-reviewed journal is planned.Trial registration number NCT02972684; Pre-results.

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

Cited by 17 publications

References 28 publications

FIBTEM clot firmness parameters correlate well with the fibrinogen concentration measured by the Clauss assay in patients and healthy subjects

FIBTEM clot firmness parameters correlate well with the fibrinogen concentration measured by the Clauss assay in patients and healthy subjects

An audit of the diagnostic accuracy of the ROTEM®sigma for the identification of hypofibrinogenaemia in cardiac surgical patients

Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study)

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