Blood-Clotting drug trial for trauma bleeding halted early

NCT ID NCT05568888

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single dose of a drug called BE1116 (a 4-factor prothrombin complex concentrate) in people with traumatic injuries and severe bleeding. The goal was to see if it could improve survival within 6 hours compared to a placebo. The trial was stopped early after enrolling 1,366 participants. Results are not yet fully available, but the study aimed to help control bleeding in emergency trauma situations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,366 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic injury

Contacts and locations

Locations

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom
Alfred Hospital

Melbourne, Victoria, 3004, Australia
Atrium Health - Medical Center of central Georgia

Macon, Georgia, 31201, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States
Barnes Jewish Hospital

St Louis, Missouri, 63110, United States
Ben Taub General Hospital - Baylor Medical Center - Harris Health Network

Houston, Texas, 77030, United States
Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States
Brown University (Rhode Island Hospital)

Providence, Rhode Island, 02903, United States
Cambridge Addenbrookes University

Cambridge, CB2 0QQ, United Kingdom
Capital Health Regional Medical Center

Trenton, New Jersey, 08638, United States
Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Chandler Regional Medical Center

Chandler, Arizona, 85224, United States
Cooper Health Care

Camden, New Jersey, 08103, United States
Dell Seton Medical Center

Austin, Texas, 78701, United States
Denver Health and Hospital Authority

Denver, Colorado, 80204, United States
Duke University

Durham, North Carolina, 27710, United States
Erie County Medical Center

Buffalo, New York, 14215, United States
Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States
Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States
George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States
Grady Memorial Hospital

Atlanta, Georgia, 30303, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Health Partners Regions Hospital

Saint Paul, Minnesota, 55101, United States
Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States
Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom
Imperial College Healthcare

London, SW7 1LY, United Kingdom
Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
J.W. Ruby Memorial Hospital

Morgantown, West Virginia, 26505, United States
JPS Health Network (John Peter Smith Hospital)

Fort Worth, Texas, 76134, United States
Jamaica Hospital Medical Center

Richmond Hill, New York, 11418, United States
John Hunter Hospital

Sydney, New Lambton, 2305, Australia
John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
LAC+USC Medical Center

Los Angeles, California, 90033, United States
LSU Health Shreveport

Shreveport, Louisiana, 71103, United States
Leeds Teaching Hospital

Leeds, LS1 3EX, United Kingdom
Liverpool Hospital

Sydney, Liverpool, NSW 2170, Australia
MedStar Washington Medical Center

Washington D.C., District of Columbia, 20010, United States
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Memorial Hermann Hospital

Houston, Texas, 77030, United States
Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States
MetroHealth Medical Center

Cleveland, Ohio, 44109, United States
NYU Langone

Mineola, New York, 11501, United States
North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States
Northeast Georgia Health System

Gainesville, Georgia, 30501, United States
Oregon Health and Sciences University Hospital

Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States
Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Regional Medical Center

Memphis, Tennessee, 38103, United States
Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States
Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States
Royal Adelaide

Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia
Royal Perth Hospital

Perth, Western Australia, 6000, Australia
Royal Prince Alfred Hospital

Sydney, New South Wales, Australia
Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom
Royal Victoria Infirmary

Newcastle upon Tyne, NE14LP, United Kingdom
Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States
SSM Health St. Louis

St Louis, Missouri, 63104, United States
San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States
Sanford Medical Center Fargo

Fargo, North Dakota, 58104, United States
Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States
Sheffield Teaching Hospital

Sheffield, S10 2JF, United Kingdom
Southmead Hospital

Bristol, BS10 5NB, United Kingdom
St. George Hospital

Kogarah, Sydney, Australia
St. Georges Hospital

London, SW17 0QT, United Kingdom
St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States
Summa Health System - Akron Campus

Akron, Ohio, 44304, United States
Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States
The Ohio State University

Columbus, Ohio, 43210, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UAB Hospital

Birmingham, Alabama, 35233, United States
UAMS Medical Center

Little Rock, Arkansas, 72205, United States
UC Davis Medical Center

Sacramento, California, 95817, United States
UC Health Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States
UC Irvine

Orange, California, 92868, United States
UC San Diego Medical Center

San Diego, California, 92103, United States
UF Health Jacksonville

Jacksonville, Florida, 32209, United States
UNMC (University of Nebraska Medical Center)

Omaha, Nebraska, 68198, United States
UT Health Tyler

Tyler, Texas, 75701, United States
University Hospital

Ann Arbor, Michigan, 48109, United States
University Hospital

San Antonio, Texas, 78229, United States
University Hospital

Madison, Wisconsin, 53792, United States
University Hospital Coventry

Coventry, CV2 2DX, United Kingdom
University Medical Center El Paso

El Paso, Texas, 79905, United States
University Medical Center Tucson

Tucson, Arizona, 85719, United States
University Medical Center of New Orleans

New Orleans, Louisiana, 70112, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States
University of Colorado Aurora

Aurora, Colorado, 80045, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40536, United States
University of Louisville Hospital

Louisville, Kentucky, 40202, United States
University of Miami/Ryder Trauma Center

Miami, Florida, 33136, United States
University of Mississippi Medical Center (UMMC)

Jackson, Mississippi, 39216, United States
University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center Presbyterian

Pittsburgh, Pennsylvania, 15213, United States
University of South Alabama

Mobile, Alabama, 36507, United States
University of Tennessee Medical Center - UTMCK

Knoxville, Tennessee, 37920, United States
University of Utah Hospital

Salt Lake City, Utah, 84132, United States
Valleywise Medical Center

Phoenix, Arizona, 85008, United States
Vanderbilt Hospital and Clinics

Nashville, Tennessee, 37027, United States
Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States
Westmead Hospital

Westmead, Sydney, 2145, Australia
Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

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