PATCH-Trauma
Trial question
What is the role of prehospital administration of tranexamic acid in patients with major trauma and suspected trauma-induced coagulopathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 1300
1300 patients (382 female, 918 male)
Inclusion criteria: adult patients with major trauma who were at risk for trauma-induced coagulopathy
Interventions
N=657 tranexamic acid (1 g bolus before hospital admission, followed by a 1 g infusion over a period of 8 hours after arrival at the hospital)
N=643 placebo (matching placebo)
Primary outcome
Survival with a favorable functional outcome at 6 months after injury
53.7
53.5
53.7 %
40.3 %
26.9 %
13.4 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
No significant difference in survival with a favorable functional outcome at 6 months after injury (53.7% vs. 53.5%; RR 1, 95% CI 0.9 to 1.12)
Secondary outcomes
Borderline significant decrease in death from any cause at day 28 (17.3% vs. 21.8%; RR 0.79, 95% CI 0.63 to 0.99)
No significant difference in death from any cause at 6 months (19% vs. 22.9%; RR 0.83, 95% CI 0.67 to 1.03)
Borderline significant decrease in death from any cause at 24 hours (9.7% vs. 14.1%; RR 0.69, 95% CI 0.51 to 0.94)
Safety outcomes
No significant differences in vascular occlusive events, other adverse events.
Conclusion
In adult patients with major trauma who were at risk for trauma-induced coagulopathy, tranexamic acid was not superior to placebo with respect to survival with a favorable functional outcome at 6 months after injury.
Reference
PATCH-Trauma Investigators and the ANZICS Clinical Trials Group, Russell L Gruen, Biswadev Mitra et al. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023 Jul 13;389(2):127-136.
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