Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Randomized Controlled Trial Multicenter Study
Enrollment with and without Exception from Informed Consent in a Pilot Trial of Tranexamic Acid in Children with Hemorrhagic Injuries.
Federal 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. ⋯ 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.