Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries
| Autor: | Linakis, Seth W, Kuppermann, Nathan, Stanley, Rachel M, Hewes, Hilary, Myers, Sage, VanBuren, John M, Casper, T Charles, Bobinski, Matthew, Ghetti, Simona, Schalick, Walton O, Nishijima, Daniel K, TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN) |
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| Rok vydání: | 2021 |
| Předmět: |
exception from informed consent
Pediatric pediatric trauma Informed Consent Physical Injury - Accidents and Adverse Effects TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network Clinical Trials and Supportive Activities Clinical Sciences Hemorrhage Pilot Projects Emergency & Critical Care Medicine tranexamic acid Tranexamic Acid Clinical Research Public Health and Health Services Humans Patient Safety Child |
| Zdroj: | Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, vol 28, iss 12 |
| Popis: | BackgroundFederal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.MethodsWe conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.ResultsWe enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12months.ConclusionsIn a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment. |
| Databáze: | OpenAIRE |
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