Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Keywords

Traumatic Injury, Wounds and Injuries, Thrombin

Eligibility

You can join if…

Open to people ages 15 years and up

  • 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

You CAN'T join if...

  • 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

  • UC Irvine not yet accepting patients
    Orange California 92868 United States
  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT05568888
Phase
Phase 3 Traumatic Injury Research Study
Study Type
Interventional
Participants
Expecting 8000 study participants
Last Updated