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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 15 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BE1116 		Administration by IV infusion
  • Drug: BE1116
    4-Factor Prothrombin Complex administered by intravenous (IV) infusion
    Other names:
    • 4-Factor Prothrombin Complex
    • Kcentra®
    • Beriplex®
Placebo Comparator
Placebo 		Administration by IV infusion
  • Drug: Placebo
    Administered by IV infusion

Recruiting Locations

UAB Hospital
Birmingham, Alabama 35233
Contact:
Central Contact

More Details

Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
+1 610-878-4000
clinicaltrials@cslbehring.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.