1. In trauma patients at risk for hemorrhage, pre-hospital administration of tranexamic acid did not significantly improve 30-day mortality compared to a placebo.
2. 30-day mortality outcomes were higher in the treatment group, when tranexamic acid was administered within 1 hour of injury, when the patient underwent severe shock, or when 2 g of tranexamic acid were administered within 8 hours of hospital arrival.
Evidence Rating Level: 1 (Excellent)
In the treatment of trauma patients at risk for hemorrhage, administering tranexamic acid during hospital care has shown improved mortality outcomes, since it is an antifibrinolytic medication that promotes blood clotting. However, current guidelines also suggest tranexamic acid be administered in a prehospital setting, despite a lack of evidence on the effectiveness and safety of this practice. The current study is a double-blind, randomized controlled trial that assessed the all-cause 30-day mortality outcomes between patients treated with tranexamic acid versus a saline placebo. During hospital care for the intervention group, patients were further subdivided in receiving 0, 1, or 2 g of additional tranexamic acid within 8 hours of arrival. The study population consisted of 903 patients (447 in the treatment group) and was conducted at four level 1 trauma centres in the US, between 2015 and 2019. The mean ±SD age was 42±18 years, and 74% were male. Overall, the study found no significant difference in 30-day mortality, with 36 deaths in the intervention and 45 deaths in the placebo (hazard ratio 0.81, 95% CI 0.59 to 1.11, p = 0.18). With regards to safety, there was no difference in arterial thrombotic complications and myocardial infarction, although 8 adverse events occurred in the treatment group, compared to 21 in the placebo group. In some cases, 30-day mortality was lowered in the treatment compared to the placebo, such as when 2 g of additional tranexamic acid was administered (mortality difference -2.7%, 95% CI -5.0 to -0.4%, p = 0.4), when tranexamic acid was administered within an hour of injury (difference -3.0%, 95% CI -5.7% to -0.3%, p < 0.002), and for patients in severe shock, defined as a systolic blood pressure lower than 70 mm Hg (difference -17%, 95% CI -25.8% to -8.1%, p < 0.003). Altogether, this study demonstrates a need to modify current guidelines on pre-hospital tranexamic acid administration for trauma.
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