A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra? / Beriplex?]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding
Primary Objective
This is a prospective, multicenter, randomized, double-blind, placebocontrolled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.
Description
Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site.
Details
Locations
Memorial Hospital Central
Principal Investigator
Thomas Schroeppel
Study ID
Protocol Number: 22-0056
More information available at ClinicalTrials.gov: NCT05568888
Categories
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