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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.

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Description

Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site.

Details
Age
Child to Adult
Eligibility
Inclusion Criteria: ~Estimated age > 15 years and weight > 50 kg (110 lbs) ~Traumatic injury with confirmed or suspected acute major bleeding and/or Revised Assessment of Bleeding and Transfusion (RABT) score > 2 ~Activation of massive transfusion protocol Exclusion Criteria: ~Cardiopulmonary resuscitation for < 5 consecutive minutes at any time before enrollment ~Isolated penetrating or blunt cranial injury, or exposed brain matter ~Isolated burns estimated to be > 20% total body surface area or suspected inhalational injury ~Known anticoagulation treatment or a history of a TEE, within the past 3 months.
Locations

Memorial Hospital Central

Principal Investigator
Photograph of Thomas Schroeppel

Thomas Schroeppel

Study ID

Protocol Number: 22-0056

More information available at ClinicalTrials.gov: NCT05568888

Categories

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