IMPORTANCE Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.OBJECTIVE To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. INTERVENTIONS Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). MAIN OUTCOMES AND MEASURESThe primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. RESULTS Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month followup. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, −0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, −2.9% [95% CI, −7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, −0.9 [95% CI, −2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, −5.4% [95% CI, −12.8% to 2.1%]; P = .16).CONCLUSIONS AND RELEVANCE Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Ou...

Background and Purpose-We derived and validated the Cincinnati Prehospital Stroke Severity Scale (CPSSS) to identify patients with severe strokes and large vessel occlusion (LVO). Methods-CPSSS was developed with regression tree analysis, objectivity, anticipated ease in administration by emergency medical services personnel and the presence of cortical signs. We derived and validated the tool using the 2 National Institute of Neurological Disorders and Stroke (NINDS) tissue-type plasminogen activator Stroke Study trials and Interventional Management of Stroke III (IMS III) Trial cohorts, respectively, to predict severe stroke (National Institutes of Health Stroke Scale [NIHSS] ≥15) and LVO. Standard test characteristics were determined and receiver operator curves were generated and summarized by the area under the curve. Results-CPSSS score ranges from 0 to 4; composed and scored by individual NIHSS items: 2 points for presence of conjugate gaze (NIHSS ≥1); 1 point for presence of arm weakness (NIHSS ≥2); and 1 point for presence abnormal level of consciousness commands and questions (NIHSS level of consciousness ≥1 each). In the derivation set, CPSSS had an area under the curve of 0.89; score ≥2 was 89% sensitive and 73% specific in identifying NIHSS ≥15. Validation results were similar with an area under the curve of 0.83; score ≥2 was 92% sensitive, 51% specific, a positive likelihood ratio of 3.3, and a negative likelihood ratio of 0.15 in predicting severe stroke. For 222 of 303 IMS III subjects with LVO, CPSSS had an area under the curve of 0.67; a score ≥2 was 83% sensitive, 40% specific, positive likelihood ratio of 1.4, and negative likelihood ratio of 0.4 in predicting LVO. Conclusions-CPSSS can identify stroke patients with NIHSS ≥15 and LVO. Prospective prehospital validation is warranted.

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