1. Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials
- Author
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Bellal Joseph, Raminder Nirula, Brian J Eastridge, Jason L Sperry, Gary Vercruysse, Francis X Guyette, Joshua B Brown, Richard S Miller, Brian G Harbrecht, Herb A Phelan, Matthew D Neal, Jack K Donohue, Nidhi Iyanna, John M Lorence, Terence O'Keeffe, Jeffrey A Claridge, Elizabeth Gimbel, and Brian J Daley
- Subjects
Surgery ,RD1-811 ,Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Abstract
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
- Published
- 2024
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