Overview
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 subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.
Eligibility
Inclusion Criteria:
- (a) Estimated age ≥ 15 years. Older minimum age is required in some locations. FOR United Kingdom: Estimated or actual age ≥ 16 years FOR Australia: Estimated or actual age ≥ 18 years AND (b) Estimated or actual 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:
- Healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization
- 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.