Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
NCT ID: NCT05568888
Last Updated: 2025-11-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
1366 participants
INTERVENTIONAL
2023-03-28
2024-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BE1116
Administration by IV infusion
BE1116
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
Placebo
Administration by IV infusion
Placebo
Administered by IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BE1116
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
Placebo
Administered by IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSL Behring
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Hospital
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Valleywise Medical Center
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
University Medical Center Tucson
Tucson, Arizona, United States
UAMS Medical Center
Little Rock, Arkansas, United States
LAC+USC Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Riverside University Health System Medical Center
Moreno Valley, California, United States
UC Irvine
Orange, California, United States
UC Davis Medical Center
Sacramento, California, United States
UC San Diego Medical Center
San Diego, California, United States
San Francisco General Hospital and Trauma Center
San Francisco, California, United States
University of Colorado Aurora
Aurora, Colorado, United States
UC Health Memorial Hospital Central
Colorado Springs, Colorado, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Medical Center
Washington D.C., District of Columbia, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
UF Health Jacksonville
Jacksonville, Florida, United States
University of Miami/Ryder Trauma Center
Miami, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Northeast Georgia Health System
Gainesville, Georgia, United States
Atrium Health - Medical Center of central Georgia
Macon, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University Medical Center of New Orleans
New Orleans, Louisiana, United States
LSU Health Shreveport
Shreveport, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
University Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Hospital
Robbinsdale, Minnesota, United States
Health Partners Regions Hospital
Saint Paul, Minnesota, United States
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, United States
SSM Health St. Louis
St Louis, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
UNMC (University of Nebraska Medical Center)
Omaha, Nebraska, United States
Cooper Health Care
Camden, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Capital Health Regional Medical Center
Trenton, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
NYU Langone
Mineola, New York, United States
Jamaica Hospital Medical Center
Richmond Hill, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Sanford Medical Center Fargo
Fargo, North Dakota, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Oregon Health and Sciences University Hospital
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Brown University (Rhode Island Hospital)
Providence, Rhode Island, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Erlanger Baroness Hospital
Chattanooga, Tennessee, United States
University of Tennessee Medical Center - UTMCK
Knoxville, Tennessee, United States
Regional Medical Center
Memphis, Tennessee, United States
Vanderbilt Hospital and Clinics
Nashville, Tennessee, United States
Dell Seton Medical Center
Austin, Texas, United States
University Medical Center El Paso
El Paso, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
JPS Health Network (John Peter Smith Hospital)
Fort Worth, Texas, United States
Ben Taub General Hospital - Baylor Medical Center - Harris Health Network
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University Hospital
San Antonio, Texas, United States
UT Health Tyler
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Harborview Medical Center
Seattle, Washington, United States
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, United States
University Hospital
Madison, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Liverpool Hospital
Sydney, Liverpool, Australia
John Hunter Hospital
Sydney, New Lambton, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Royal Adelaide
Adelaide, South Australia, Australia
St. George Hospital
Kogarah, Sydney, Australia
Westmead Hospital
Westmead, Sydney, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Cambridge Addenbrookes University
Cambridge, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Leeds Teaching Hospital
Leeds, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
St. Georges Hospital
London, , United Kingdom
Imperial College Healthcare
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Sheffield Teaching Hospital
Sheffield, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-005060-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BE1116_3006
Identifier Type: -
Identifier Source: org_study_id