This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in patients with traumatic injury and confirmed or suspected acute major bleeding predicted to receive a large volume blood product transfusion. Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site. Subjects will receive a single IV infusion of either BE1116 or placebo, in addition to the study site's standard resuscitation methods and protocol.
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When you have an unexpected injury or illness, is it better to go to an urgent care center or the emergency room? It's important to understand your options.