In the Pre-hospital Antifibrinolytics for Traumatic Coagulopathy and Hemorrhage (PATCH-Trauma) trial, functional outcomes at 6 months in adults with major trauma and suspected trauma-induced coagulopathy were similar for tranexamic acid and placebo. “Longitudinal studies of trauma patients in equivalent populations have shown that some patients have functional improvement beyond 6 months,” the authors write. “Our data do not preclude the possibility that tranexamic acid can prevent early death from bleeding in some patients who will go on to make a good recovery. However … our findings do not provide a basis for identifying such patients in the prehospital setting.”
Adults with major trauma who were at risk for trauma-induced coagulopathy were randomized to intravenous tranexamic acid 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital, or matched placebo. Based on a primary outcome of survival with a favorable functional outcome at 6 months after injury (assessed with the use of the Glasgow Outcome Scale–Extended [GOS-E]), the authors found these results: “A total of 1,310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups.”
Editorial: “What are the implications of these results for prehospital care?” editorialists write. “The PATCH-Trauma trial helps to move trauma investigation beyond the consideration of survival alone. We want patients to survive and recover fully. But is less than full recovery at 6 months or even longer without value? It is hard to imagine that doctors or paramedics would withhold a treatment that saves lives in the short-term because survivors may be severely disabled at 6 months. One of us (H.S.-S.) has personal experience of a severe traumatic brain injury and hemorrhage with full recovery only after 2 years. Disability is not a constant characteristic of a person but the result of an interaction between the person and the environment, and both change over time. Furthermore, severe disability does not necessarily equate to a poor quality of life. A study of the relationship between disability and health-related quality of life after traumatic brain injury showed that one third to one half of patients with severe disability according to the GOS-E reported health-related quality of life within the normal range. Effective rehabilitation could improve outcomes, but rehabilitation after trauma is a weak link even in advanced systems. We should also consider extending the use of tranexamic acid to a wider group of trauma victims, including those with less severe injury with more potential for disability-free survival.”