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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

University of South Alabama
Mobile, Alabama 36507
Contact:
Central Contact

Chandler Regional Medical Center
Chandler, Arizona 85224
Contact:
Central Contact

Valleywise Medical Center
Phoenix, Arizona 85008
Contact:
Central Contact

St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
Contact:
Central Contact

HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona 85251
Contact:
Central Contact

University Medical Center Tucson
Tucson, Arizona 85719
Contact:
Central Contact

UAMS Medical Center
Little Rock, Arkansas 72205
Contact:
Central Contact

Riverside University Health System Medical Center
Moreno Valley, California 92555
Contact:
Central Contacts

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Central Contact

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Central Contact

George Washington University Hospital
Washington, District of Columbia 20037
Contact:
Central Contact

UF Health Jacksonville
Jacksonville, Florida 32209
Contact:
Central Contact

University of Miami/Ryder Trauma Center
Miami, Florida 33136
Contact:
Central Contact

Grady Memorial Hospital
Atlanta, Georgia 30303
Contact:
Central Contact

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Central Contact

Northeast Georgia Health System
Gainesville, Georgia 30501
Contact:
Central Contact

Atrium Health - Medical Center of central Georgia
Macon, Georgia 31201
Contact:
Central Contact

St. Vincent's Hospital
Indianapolis, Indiana 46260
Contact:
Central Contact

LSU Health Shreveport
Shreveport, Louisiana 71103
Contact:
Central Contact

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Central Contact

University Hospital
Ann Arbor, Michigan 48109
Contact:
Central Contact

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Central Contact

Health Partners Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Central Contact

University of Mississippi Medical Center (UMMC)
Jackson, Mississippi 39216
Contact:
Central Contact

Barnes Jewish Hospital
Saint Louis, Missouri 63110
Contact:
Central Contact

Capital Health Regional Medical Center
Trenton, New Jersey 08638

Jamaica Hospital Medical Center
Richmond Hill, New York 11418
Contact:
Central Contact

Carolinas Medical Center
Charlotte, North Carolina 28203
Contact:
Central Contact

Duke University
Durham, North Carolina 27710
Contact:
Central Contact

Wake Forest Medical Center
Winston-Salem, North Carolina 27157
Contact:
Central Contact

Sanford Medical Center Fargo
Fargo, North Dakota 58104
Contact:
Central Contact

Summa Health System - Akron Campus
Akron, Ohio 44304
Contact:
Central Contact

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Central Contact

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Central Contact

Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
Contact:
Central Contact

University of Oklahoma Health Science Center
Oklahoma City, Oklahoma 73104
Contact:
Central Contact

Oregon Health and Sciences University Hospital
Portland, Oregon 97239
Contact:
Central Contact

Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
Contact:
Central Contact

Temple University Hospital
Philadelphia, Pennsylvania 19140
Contact:
Central Contact

University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania 15213
Contact:
Central Contract

Brown University (Rhode Island Hospital)
Providence, Rhode Island 02903
Contact:
Central Contact

Sanford USD Medical Center
Sioux Falls, South Dakota 57117

Erlanger Baroness Hospital
Chattanooga, Tennessee 37403
Contact:
Central Contact

Vanderbilt Hospital and Clinics
Nashville, Tennessee 37027
Contact:
Central Contact

Dell Seton Medical Center
Austin, Texas 78701
Contact:
Central Contact

JPS Health Network (John Peter Smith Hospital)
Fort Worth, Texas 76134
Contact:
Central Contact

Ben Taub General Hospital - Baylor Medical Center - Harris Health Network
Houston, Texas 77030
Contact:
Central Contact

Intermountain Medical Center
Murray, Utah 84107
Contact:
Central Contact

Harborview Medical Center
Seattle, Washington 98104
Contact:
Central Contact

J.W. Ruby Memorial Hospital
Morgantown, West Virginia 26505
Contact:
Central Contact

Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin 53226
Contact:
Central Contact

More Details

NCT ID
NCT05568888
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.