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The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.Severely injured children (0 up to 18A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

BACKGROUND: Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer’s [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock. METHODS: Open-label pragmatic randomized controlled trial at a single academic children’s hospital from January to August 2018. Eligible patients were >6 months to

OBJECTIVES: In preparation for a clinical trial of therapeutic agents for children with moderate-to-severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to 1) determine the number and clinical characteristics of eligible children, 2) determine the timing of patient and guardian arrival to the ED, and 3) describe the heterogeneity of TBIs on computed tomography (CT) scans. METHODS: We conducted a prospective observational study at 16 EDs of children ≤ 18 years of age presenting with blunt head trauma and Glasgow Coma Scale (GCS) scores of 3-12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings. RESULTS: We enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and non-survivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2 hours of injury, but most guardians did not arrive until 2-3 hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common. CONCLUSION: Enrolling children with moderate-to-severe TBI into time sensitive clinical trials will require large numbers of sites, meticulous preparation and coordination, and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved. Language: en

Objectives: To describe the epidemiology of repeat users of the emergency department (ED) using a statewide database. Methods: Probabilistic linkage was used to convert three years of statewide ED visit data into a longitudinal, patient-based data set. Patients were classified as single, repeat (at least two visits within three years), or serial (four or more visits within a 365-day period) users of the ED. Serial patients were further stratified by the number of EDs attended. Descriptive statistics were used to assess differences between patient types. Results: There were 1,370,607 separate visits associated with 780,074 patients from 1996 to 1998. While repeat and serial patients represented 33% of the patients, they accounted for 62% of the ED visits during the study period. Repeat and serial patients were younger and had smaller median ED charges per visit than single-use patients. Serial patients attending five or more EDs were more likely to be coded as self-pay than other serial patients. Diagnosis codes relating to sprains, back problems, and headaches were prevalent among serial patients who visited five or more EDs. Approximately 30% of serial patients during the first year remained serial patients in the second year. Conclusions: Due to the high turnover in serial patients, control groups in future studies are necessary to evaluate interventions aimed at decreasing serial ED use. The likelihood of serial ED users to use multiple EDs indicates that those studying serial ED use should collect data from multiple EDs.