Prehospital Tranexamic Acid for Severe Trauma.

BACKGROUND: Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain. METHODS: We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered 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) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury. RESULTS: A total of 1310 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. CONCLUSIONS: Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).

Gender differences in outcome in patients with hypotension and severe traumatic brain injury.

BACKGROUND: Animal studies have identified hormonal influences on responses to injury and recovery, creating a potential gender effect on outcome. Progesterone and oestrogen are thought to afford protection in the immediate post-injury period, suggesting females have an advantage, although there has been limited evidence of this in human outcome studies. METHODS: This study examined the influence of gender on outcome in 229 adults (151 males), aged >17 years, with severe blunt head trauma, initial GCS <9 and hypotension, recruited into a randomised controlled trial of pre-hospital hypertonic saline resuscitation versus conventional fluid management. Outcome was measured by survival and Glasgow Outcome Scale-Extended version (GOS-E) scores at 6 months post-injury. RESULTS: Females recruited into the study had a higher mean age. Females were more likely to be injured as passengers and pedestrians and males as drivers or motorcyclists. There were no gender differences in GCS or injury severity scores, ICP, cerebral perfusion pressure, gas exchange (PaO2/FiO2 ratio), or duration of mechanical ventilation. After controlling for GCS, age and cause of injury, females had a lower rate of survival. They also showed a lower rate of good outcome (GOS-E score >4) at 6 months, but this appeared to reflect the lower rate of initial survival. Those females surviving had similar outcomes to males. CONCLUSIONS: The study provides no evidence that females fare better than males following severe TBI, suggesting rather that females may fare worse.