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Evaluation of BE1116 (4F-PCC) in patients with traumatic injury and confirmed or suspected acute major bleeding to improve survival

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 Confirmed or Suspected Acute Major Bleeding Predicted to Receive a Large Volume Blood Product Transfusion

All genders
person-wave 15+
Recruiting now
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Principal Investigator: Nikolay Bugaev, MD

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 patients with traumatic injury and confirmed or suspected acute major bleeding predicted to receive a large volume blood product transfusion. Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site. Subjects will receive a single IV infusion of either BE1116 or placebo, in addition to the study site's standard resuscitation methods and protocol. The dose of BE1116 will be either 2000 IU or 3000 IU, based on the weight of the subject (estimated or measured) on arrival at the emergency department (ED): Weight < 75 kg (< 165 lbs): 2000 IU. Weight ≥>= 75 kg (≥ 165 lbs): 3000 IU. Due to the emergent nature of this study, the study will be conducted under an Exception From Informed Consent (EFIC) option or equivalent.

Study details

Inclusion Criteria
  • 1. Estimated age >= ≥ 15 years or weight > 50 kg (110 lbs) if age unknown
  • 2. Traumatic injury with confirmed or suspected acute major bleeding
  • 3. Anticipation by the attending trauma physician (or delegate) of administration of a large volume transfusion based on clinical gestalt / assessment or Revised Assessment of Bleeding and Transfusion (RABT) score >=≥ 2
Exclusion Criteria
  • 1. Cardiopulmonary resuscitation for >=≥ 5 consecutive minutes at any time before enrollment
  • 2. Isolated penetrating or blunt cranial injury, or exposed brain matter
  • 3. Known anticoagulation treatment or a history of a TEE, within the past 3 months
Study Requirements

The study consists of: (i) a Screening and Enrollment Period: the patient will have their vital signs and body weight recorded, undergo a physical examination, glasgow coma scale, RABT score and will be randomized to placebo or investigational product (IP) KCentra. (ii) a Treatment Period: IP infusion or placebo begins within 90 minutes after arrival to Emergency Department (iii) an In-hospital Follow-up Period: the patient is followed until death/hospital discharge/ Day 30, whichever occurs first

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