for people ages 15 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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.

Official Title

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


Traumatic Injury, Wounds and Injuries, Thrombin


You can join if…

Open to people ages 15 years and up

  • (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

You CAN'T join if...

  • 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.


  • San Francisco General Hospital and Trauma Center not yet accepting patients
    San Francisco California 94110 United States
  • UC Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • UC Irvine accepting new patients
    Orange California 92868 United States
  • Riverside University Health System Medical Center accepting new patients
    Moreno Valley California 92555 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
CSL Behring
Phase 3 Injury Research Study
Study Type
Expecting 8000 study participants
Last Updated