In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427 .).

In-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients.OBJECTIVE To assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage.DESIGN, SETTING, AND PARTICIPANTS This pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure Յ90 mm Hg) or tachycardia (heart rate Ն110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019.INTERVENTIONS Patients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival. MAIN OUTCOMES AND MEASURESThe primary outcome was 30-day all-cause mortality.RESULTS In all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placebo intervention). After exclusions, the intention-to-treat study cohort comprised 903 patients: 447 in the tranexamic acid arm and 456 in the placebo arm. Mortality at 30 days was 8.1% in patients receiving tranexamic acid compared with 9.9% in patients receiving placebo (difference, -1.8%; 95% CI, -5.6% to 1.9%; P = .17). Results of Cox proportional hazards regression analysis, accounting for site, verified that randomization to tranexamic acid was not associated with a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18). Prespecified dosing regimens and post-hoc subgroup analyses found that prehospital tranexamic acid were associated with significantly lower 30-day mortality. When comparing tranexamic acid effect stratified by time to treatment and qualifying shock severity in a post hoc comparison, 30-day mortality was lower when tranexamic acid was administered within 1 hour of injury (4.6% vs 7.6%; difference, −3.0%; 95% CI, −5.7% to −0.3%; P < .002). Patients with severe shock (systolic blood pressure Յ70 mm Hg) who received tranexamic acid demonstrated lower 30-day mortality compared with placebo (18.5% vs 35.5%; difference, −17%; 95% CI, −25.8% to −8.1%; P < .003). CONCLUSIONS AND RELEVANCEIn injured patients at risk for hemorrhage, tranexamic acid administered before hospitalization did not result in significantly lower 30-day mortality. The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events. Tranexamic acid given to injured patient...

BACKGROUND Undertriage is a concern in geriatric patients. The National Trauma Triage Protocol (NTTP) recognized that systolic blood pressure (SBP) less than 110 mm Hg may represent shock in those older than 65 years. The objective was to evaluate the impact of substituting an SBP of less than 110 mm Hg for the current SBP of less than 90 mm Hg criterion within the NTTP on triage performance and mortality. METHODS Subjects undergoing scene transport in the National Trauma Data Bank (2010–2012) were included. The outcome of trauma center need was defined as Injury Severity Score (ISS) greater than 15, intensive care unit admission, urgent operation, or emergency department death. Geriatric (age > 65 years) and adult (age, 16–65 years) cohorts were compared. Triage characteristics and area under the curve (AUC) were compared between SBP of less than 110 mm Hg and SBP of less than 90 mm Hg. Hierarchical logistic regression was used to determine whether geriatric patients newly triaged positive under this change (SBP, 90–109 mm Hg) have a risk of mortality similar to those triaged positive with SBP of less than 90 mm Hg. RESULTS There were 1,555,944 subjects included. SBP of less than 110mm Hg had higher sensitivity but lower specificity in geriatric (13% vs. 5%, 93% vs. 99%) and adult (23% vs. 10%, 90% vs. 98%) cohorts. AUC was higher for SBP of less than 110 mm Hg individually in both geriatric and adult (p < 0.01) cohorts. Within the NTTP, the AUC was similar for SBP of less than 110 mm Hg and SBP of less than 90 mm Hg in geriatric subjects but was higher for SBP of less than 90 mm Hg in adult subjects (p < 0.01). Substituting SBP of less than 110 mm Hg resulted in an undertriage reduction of 4.4% with overtriage increase of 4.3% in the geriatric cohort. Geriatric subjects with SBP of 90 mm Hg to 109 mm Hg had an odds of mortality similar to those of geriatric patients with SBP of less than 90 mm Hg (adjusted odds ratio, 1.03; 95% confidence interval, 0.88–1.20; p = 0.71). CONCLUSION SBP of less than 110 mm Hg increases sensitivity. SBP of less than 110 mm Hg has discrimination as good as that of SBP of less than 90 mm Hg, with superior improvements in undertriage relative to overtriage in geriatric patients. Geriatric patients newly triaged to be positive under this change have a risk of mortality similar to those under the current SBP criterion. This change in SBP criteria may be merited in geriatric patients, warranting further study to consider elevation to a Step 1 criterion in the NTTP. LEVEL OF EVIDENCE Diagnostic study, level IV