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Background
The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We assessed the feasibility of a large‐scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.
Methods
Severely injured children (0 up to 18th birthday) were randomized into a double‐blind...
Background
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.
Methods
We conducted a four‐center randomized controlled pilot and...
Background Trauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to...
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