Substitution of ROTEM FIBTEM A5 for A10 in trauma: an observational study building a case for more rapid analysis of coagulopathy

Abstract

Purpose

Rotational thromboelastometry (ROTEM®) allows guided blood product resuscitation to correct trauma-induced coagulopathy in bleeding trauma patients. FIBTEM amplitude at 10 min (A10) has been widely used to identify hypofibrinogenaemia; locally a threshold of < 11 mm has guided fibrinogen replacement. Amplitude at 5 min (A5) carries an inherent time advantage. The primary aim was to explore the relationship between FIBTEM A5 and A10 in a trauma. Secondary aim was to investigate the use of A5 as a surrogate for A10 within a fibrinogen-replacement algorithm.

Methods

Retrospective observational cohort study of arrival ROTEM results from 1539 consecutive trauma patients at a Level 1 trauma centre in Australia. Consistency of agreement between FIBTEM A5 and A10 was assessed. A new fibrinogen replacement threshold was developed for A5 using the A5–A10 bias; this was clinically compared to the existing A10 threshold.

Results

FIBTEM A5 displayed excellent consistency of agreement with A10. Intraclass correlation coefficient = 0.972 (95% confidence interval [CI] 0.969–0.974). Bias of A5 to A10 was − 1.49 (95% CI 1.43–1.56) mm. 19.34% patients met the original local threshold of A10 < 11 mm; 19.28% patients met the new, bias-adjusted threshold of A5 < 10 mm.

Conclusion

ROTEM FIBTEM A5 reliably predicts A10 in trauma. This further validates use of the A5 result over A10 allowing faster decision-making in time-critical resuscitation of trauma patients. A modification of -1 to the A10 threshold might be appropriate for use with the A5 value in trauma patients.

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Data availability

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

Abbreviations

ROTEM:

Rotational thromboelastometry

A5:

Amplitude at five minutes

A10:

Amplitude at ten minutes

MCF:

Maximum clot firmness

TIC:

Trauma-induced coagulopathy

DCR:

Damage control resuscitation

ICC:

Intra-class correlation

ISS:

Injury severity score

PRC:

Packed red cells

INR:

International normalised ratio

IQ:

Interquartile

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Acknowledgements

Dr Ian Hughes: Office for Research Governance and Development, Gold Coast Health.

Funding

The authors declare no external funding sources.

Author information

Affiliations

Authors

Contributions

AB consolidated the databases and wrote the manuscript. JM ran the statistical analyses. KW, EW, DH, EC, AC collected the primary data. DC facilitated the running of the study and data collection. JW led the study. All authors read and reviewed the manuscript prior to submission.

Corresponding author

Correspondence to Alexander Blayney.

Ethics declarations

Conflict of interest

The authors (Alexander Blayney, James P.A. McCullough, Elizabeth Wake, Kerin Walters, Don Campbell, Debbie Ho, Erick Chan, Aashish Chalasani and James Winearls) declare that they have no conflict of interest.

Ethical approval

This study was performed according to the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Ethics approval was obtained from the Gold Coast Hospital and Health Service Human Research Ethics Committee on the 26th March 2014 (HREC/14/QGC/17).

Informed consent

Waived consent was granted as section 2.3 of the National Statement on Ethical Conduct in Human Research.

Supplementary Information

Below is the link to the electronic supplementary material.

68_2021_1652_MOESM1_ESM.pdf

Supplementary Additional File 1 PDF of the local current ROTEM transfusion algorithm for critical bleeding. See “Step 2” (interpretation of FIBTEM for fibrinogen replacement). It should be noted that the exact wording of the algorithm differs slightly to that used in the report: The algorithm uses ≤ 10 mm as a threshold; this is expressed as < 11 mm in the report to facilitate direct comparison to the literature. As the outputs from the ROTEM are expressed as integers, the interpretation of these two thresholds is identical (PDF 375 KB)

68_2021_1652_MOESM2_ESM.pdf

Supplementary Additional File 2 PDF of the Trauma criteria used to define patients for our cohort. The local service operates a two tier trauma activation protocol: “Alert” and “Respond”. For the purposes of this study, patients meeting criteria for either tier were included in our trauma cohort (PDF 183 KB)

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Blayney, A., McCullough, J., Wake, E. et al. Substitution of ROTEM FIBTEM A5 for A10 in trauma: an observational study building a case for more rapid analysis of coagulopathy. Eur J Trauma Emerg Surg (2021). https://doi.org/10.1007/s00068-021-01652-w

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Keywords

  • ROTEM
  • Rotational thromboelastometry
  • Fibrinogen
  • Trauma
  • Haemorrhage
  • Coagulopathy
  • Resuscitation