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

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

  • Traumatic Injury

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