PATCH Trauma Trial

What was the research question?

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

• Intervention: Administration of tranexamic acid intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital.

• Comparison: Matched placebo group.

• Outcome: Primary outcome was survival with a favorable functional outcome at 6 months after injury, assessed using the Glasgow Outcome Scale–Extended (GOS-E), with secondary outcomes being death from any cause within 28 days and within 6 months after injury.

How did they do it?

• The researchers randomly assigned 1310 adults with major trauma at risk for trauma-induced coagulopathy to receive either tranexamic acid or placebo.

• Primary outcome: Survival with a favorable functional outcome at 6 months post-injury, assessed using the GOS-E.

• Secondary outcome: Death from any cause within 28 days and within 6 months post-injury.

What were the results?

• The primary outcome was not significantly different between the two groups (53.7% in the tranexamic acid group and 53.5% in the placebo group; risk ratio, 1.00; 95% CI, 0.90 to 1.12; P=0.95).

• In terms of secondary outcomes, fewer patients died within 28 days and 6 months in the tranexamic acid group than in the placebo group. This difference was statistically significant for death within 28 days but not for death within 6 months. The occurrence of serious adverse events was similar in both groups.

Are there any limitations of the study?

• Potential limitation could be the unknown trial-group assignment for 3 patients.

• Generalizability might be limited as the study was conducted only in Australia, New Zealand, and Germany.

• The study did not provide information about long-term outcomes beyond 6 months.

• The effect of other potential confounding treatments that patients might have received was not accounted for.

What does it mean?

• Prehospital administration of tranexamic acid did not lead to a greater number of patients surviving with a favorable functional outcome at 6 months compared to placebo among adults with major trauma and suspected trauma-induced coagulopathy.

• Despite this, it's important to note that tranexamic acid showed a statistically significant reduction in deaths within 28 days, although this did not extend to 6 months.

• The finding might not change current practice in critical care due to the lack of a significant difference in the primary outcome. However, the observed reduction in mortality within 28 days in the tranexamic acid group warrants further investigation.