Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

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.