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evident
Original paper
2023NEJMEmergency Medicine

PATCH-Trauma

Prehospital Tranexamic Acid for Severe Trauma

RCTTrauma

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Overview

Prehospital TXA did not improve 6-month favorable functional outcome after major trauma in advanced trauma systems.

Clinical takeaway

PATCH-Trauma cautions that early TXA in mature prehospital systems may not produce better 6-month function even if fewer patients have died by 28 days.

Key result

Favorable 6-month functional outcome was 53.7% with prehospital TXA vs 53.5% with placebo (RR 1.00).

Practice impact

Do not treat prehospital TXA as proven to improve long-term function after major trauma.

Evidence

Study design

Randomized, placebo-controlled trial.

Enrollment

1,310

Follow-up

Survival with a favorable functional outcome at 6 months; death also assessed at 28 days and 6 months.

Geography

Australia, New Zealand, Germany

Clinical question

Does prehospital tranexamic acid increase survival with a favorable functional outcome at 6 months after major trauma?

Population

  • Adults with major trauma at risk for trauma-induced coagulopathy, treated in advanced trauma systems.

Intervention

Tranexamic acid 1 g IV bolus before hospital admission, then 1 g infused over 8 hours after hospital arrival.

Comparator

Matched placebo.

Primary outcome

Survival with a favorable functional outcome at 6 months (GOS-E of 5 or higher).

Prehospital TXA followed by an 8-hour infusion did not increase survival with a favorable functional outcome at 6 months.

Risk ratio / 1 / 95% CI 0.90-1.12 / p=0.95

Key results

  • Favorable 6-month functional outcome occurred in 53.7% with TXA vs 53.5% with placebo; RR 1.00 (95% CI 0.90-1.12; P=0.95).
  • Death at 28 days was 17.3% with TXA vs 21.8% with placebo; RR 0.79 (95% CI 0.63-0.99).
  • Death at 6 months was 19.0% vs 22.9%; RR 0.83 (95% CI 0.67-1.03).
  • Serious adverse events, including vascular occlusive events, did not differ meaningfully.

Harms

  • The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between groups.

Clinical Use

Practice impact

  • Do not treat prehospital TXA as proven to improve long-term function after major trauma.

Applicability

  • Most applicable to adults with major trauma and suspected trauma-induced coagulopathy treated in advanced trauma systems.

Limitations

  • The primary functional outcome was available for 572 TXA and 559 placebo patients, fewer than the number assigned.
  • The trial was conducted in advanced trauma systems in Australia, New Zealand, and Germany.
  • Lower 28-day mortality was a secondary finding, not the primary outcome.

Common misinterpretations

  • A neutral functional primary outcome is not the same as no effect on early death.
  • This trial tests prehospital TXA plus an 8-hour infusion against 6-month function; it does not erase earlier in-hospital TXA evidence.

Related evidence

CRASH-2 - Earlier TrialCRASH-3 - Similar Question

Citation

PATCH-Trauma Investigators and the ANZICS Clinical Trials Group, Gruen RL, Mitra B, et al. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023;389(2):127-136. doi:10.1056/NEJMoa2215457

Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo.