PATCH-Trauma
Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 1310 adults with major trauma at coagulopathy risk, prehospital tranexamic acid did not improve 6-month survival with favourable function versus placebo.
N
1.310
Design
Multicentre, double-blind, randomised, placebo-controlled trial in 15 emergency medical services in Australia, New Zealand and Germany; adults with major trauma at risk of trauma-induced coagulopathy (Coagulopathy of Severe Trauma score ≥3) received 1 g intravenous tranexamic acid before hospital admission followed by a 1-g infusion over 8 hours, or matching placebo
Endpunkt
Primary: survival with a favourable functional outcome at 6 months, defined as Glasgow Outcome Scale–Extended (GOS-E) level ≥5. Secondary outcomes included death from any cause within 28 days and within 6 months, and vascular occlusive events
ErgebnisFavourable functional survival at 6 months in 307/572 (53.7%) with tranexamic acid vs 299/559 (53.5%) with placebo (risk ratio 1.00; 95% CI 0.90–1.12; P=0.95). Death within 28 days 113/653 (17.3%) vs 139/637 (21.8%) (RR 0.79; 95% CI 0.63–0.99); death by 6 months 123/648 (19.0%) vs 144/629 (22.9%) (RR 0.83; 95% CI 0.67–1.03). Serious adverse events, including vascular occlusive events, did not differ meaningfully between groups
PATCH-Trauma Investigators and the ANZICS Clinical Trials Group. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023;389(2):127-136. 10.1056/nejmoa2215457