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Background Tranexamic acid (TXA) has been hypothesized to mitigate coagulopathy in patients after traumatic injury. Despite previous prehospital clinical trials demonstrating a TXA survival benefit, none have demonstrated correlated changes in thromboelastography (TEG) parameters. We sought to analyze if missing TEG data contributed to this paucity of findings.Methods We performed a secondary analysis of the Study of Tranexamic Acid During Air Medical and Ground Prehospital Transport Trial. We compared patients that received TEG (YES-TEG) and patients unable to be sampled (NO-TEG) to analyze subgroups in which to investigate TEG differences. TEG parameter differences across TXA intervention arms were assessed within subgroups disproportionately present in the NO-TEG relative to the YES-TEG cohort. Generalized linear models controlling for potential confounders were applied to findings with p

Background The reporting of adverse events (AEs) is required and well defined in the execution of clinical trials, but is poorly characterized particularly in prehospital trials focusing on traumatic injury. In the setting of prehospital traumatic injury trials, no literature currently exists analyzing the clinical implications of AEs and their associations with mortality and morbidity. We sought to analyze AEs from three prehospital hemorrhagic shock trials and characterize their time course, incidence, severity, associated clinical outcomes, and relatedness.Methods We performed a secondary analysis of three prehospital randomized clinical trials. We analyzed AEs at both the patient level as well as the individual AE level. We categorized patients who had no AEs, a single documented AE and those with multiple events (>1 AE). We characterized AE timing, severity, relatedness and attributable mortality outcomes.Results We included 1490 patients from the three harmonized clinical trials, with 299 (20.1%) individual patients having at least a single AE documented with 529 AEs documented overall as a proportion of patients had multiple events. Over 44% of patients had a death-related misclassified AE. Patients with at least a single documented AE had a significantly higher 28-day mortality (log-rank χ2=81.27, p

High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods.

As trauma surgeons, we focus on the immediate care and needs of the injured patient every day. Historically, trauma and injury research has focused on outcomes such as mortality, complications, and length of stay; and process metrics such as time to CT scan, resuscitation checklist frequencies, or venous thromboembolism prophylaxis rates. These outcomes are perceived by healthcare providers to be important, but patients likely have different perceptions of what outcomes are most important to measure and improve. True patient-centered outcomes research involves the healthcare providers, and the entire team of stakeholders including patients and the community. Understanding the process of stakeholder engagement and the barriers trauma researchers must overcome to effectively enter this field of research is important. This summary aims to inform the trauma research community on the basics of patient-centered outcomes research, priorities for funding from the Patient-Centered Outcomes Research Institute, resources for collaboration around patient-centered outcomes research, and a unique career development and training opportunity for early career trauma surgeons to develop a skill set in patient-centered outcomes research.

This paper describes the current funding, infrastructure growth and future state of trauma research. It also introduces a group of review articles generated from The Future of Trauma Research: Innovations in Research Methodology conference hosted by the American College of Surgeons Committee on Trauma in July 2019.