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Authors: Rob Hirst, Andy Neill, Dave McCreary, Becky Maxwell, Chris Connolly / Codes: CAP18, RP4, SLO1, TP1 / Published: 04/07/2023

 

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Clinical Question

Does TXA improve outcomes in sick bleeding trauma patients?

Title of Paper

Prehospital Tranexamic Acid for Severe Trauma

Journal and Year

NEJM. 2023.

Lead Author

PATCH-Trauma Investigators

Russel Gruen

Background

  • CRASH-2 (2010) was a massive (20k patients) international RCT that showed a 1.5% ARR in mortality for trauma patients bleeding or “at risk of bleeding”
  • Some systems (I’m looking at you, UK) embraced TXA ++ based on this study, and have made it a fundamental part of their management of the bleeding trauma patient.
  • But with questions over applicability to developed, organised trauma systems – other systems (such as the one I’m working in in Australia) haven’t protocolised it quite so much and felt it needed some further assessment.

Study Design

  • International, double-blind, randomised, placebo-controlled trial

Patients Studied

  • Adults
  • Suspected severe traumatic injury → major trauma centre
  • High risk for trauma-induced coagulopathy
    • COAST score ≥3. Thats a score of 0-7 with 1 for each of:
      • Entrapment
      • SBP <100mmHg
      • T<35
      • Suspected pneumothorax
      • Suspected intraabdominal/pelvic injury
      • More points for:
        • SBP <90mmHg
        • T<32
  • Inpatients had screening for DVT at around day 7

Intervention

  • TXA 1g IV over 10mins then 8h infusion

Comparison

  • Placebo of same

Outcomes

  • Primary: Glasgow Outcome Scale-Extended (GOS-E) at 6 months, dichotomised into Unfavourable (1-4) and Favourable (>4)

    1. Dead
    2. Vegetative state
    3. Lower severe disability: fully dependent for all ADLs, requiring constant assistance, can’t be left alone at night
    4. Upper severe disability: can be left alone for up to 8 hours but remains dependent
    5. Lower moderate disability: able to return to work in sheltered workshop or non-competitive job.
    6. Upper moderal disability
    7. Lower good recovery
    8. Upper good recovery
  • Secondary:

    • Death: 24h, 28d, 6m
    • Cause of death: bleeding, vasc occlusion, MOF, TBI, other.

Summary of Results

  • Powered to find 9% difference in functional outcome: 1184 patients → 1316 increased due to 10% loss to follow-up.
  • 1131 patients:
    • Mostly male
    • Mostly blunt
    • ~1/3 had SBP≥90
    • ~1/3 had sTBI (GCS<9)
    • Median ISS 29
    • 24% had early coagulopathy on labs

Primary:

  • No difference GOS-E ≥ 5 between the groups on ITT analysis:
    • TXA 53.7% TXA and
    • placebo 53.5%

Secondary:

  • Death
    • 24h: 9.7% TXA | 14.1% placebo (RR 0.69 [0.51-0.94])
    • 28d: 17.3% TXA | 21.8% placebo (RR 0.79 [0.63-0.99])
    • 6m: 19% TXA | 22.9% placebo (RR 0.83 [0.67-1.03])
  • VTE: no difference

When you look at the individual GOS-E scores, it looks like the slight improvement in survivors just increased the GOS-E 3 (lower severe disability) group.

Authors Conclusion

Among adults with major trauma who were at risk for trauma induced coagulopathy and were receiving treatment in advanced trauma systems, TXA appeared to be associated with lower early mortality, but did not result in a higher percentage of patients surviving with a favourable functional outcome at 6 months than placebo.

Clinical Bottom Line

I’ll probably keep / go back to (now the trial is over) using TXA for bleeding trauma patients. I think there is sufficient evidence now that its at least not causing any harm (in terms of VTE) and there may be some benefit in mortality. 6 months is early for assessment of a functional outcome for severely injured patients so it’ll be interesting to see results of longer term follow up. In the meantime, at least the conversion seems to be death → severe dependency rather than to a persistent vegetative state.

As Andy and I both noted in the recording, however, while TXA may be of some mortality benefit (NNT of 25 or 68 depending on study) – that is nowhere near the benefit of some of the more immediate interventions in trauma, and so lets not all get distracted by the giving of TXA over getting the basics done well.

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www.nice.org.uk head injury assessment and early management

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Authors:

Dave McCreary & Joseph Mathew

A/Prof Joseph Mathew is Deputy Director of the Alfred’s Trauma service, an emergency phsyician, and the chief instructor of the Alfred’s Procedure Course. In this segment I talk to him about HALO procedures, and discuss some of the procedures taught on The Procedures Course.

Some of the links and references we mention in our discussion are below.

If you’re interested in learning these procedures on our cadaveric course, The Procedures Course is coming to Cambridge on 30th September – 1st October 2023, and RCEM members are getting a 500 Euro discount so check out the link to find out more and register.

Links:

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The Dying Patient

Applying for Grants, Fellowships and Personal Awards

Eating Disorders in the ED

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