Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.
Seth W LinakisNathan KuppermannRachel M StanleyHilary HewesSage MyersJohn M VanBurenT Charles CasperMatthew BobinskiSimona GhettiWalton O SchalickDaniel K Nishijimanull nullPublished in: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine (2021)
In 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.