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

November 24, 2025 updated by: CSL Behring

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients With Traumatic Injury and Acute Major Bleeding

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Liverpool
      • Sydney, Liverpool, Australia, NSW 2170
        • Liverpool Hospital
    • New Lambton
      • Sydney, New Lambton, Australia, 2305
        • John Hunter Hospital
    • New South Wales
      • Sydney, New South Wales, Australia
        • Royal Prince Alfred Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide
    • Sydney
      • Kogarah, Sydney, Australia
        • St. George Hospital
      • Westmead, Sydney, Australia, 2145
        • Westmead Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge Addenbrookes University
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Teaching Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital
      • London, United Kingdom, SW17 0QT
        • St. Georges Hospital
      • London, United Kingdom, SW7 1LY
        • Imperial College Healthcare
      • Newcastle upon Tyne, United Kingdom, NE14LP
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Hospital
      • Mobile, Alabama, United States, 36507
        • University of South Alabama
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center Phoenix
      • Phoenix, Arizona, United States, 85008
        • Valleywise Medical Center
      • Scottsdale, Arizona, United States, 85251
        • HonorHealth Scottsdale Osborn Medical Center
      • Tucson, Arizona, United States, 85719
        • University Medical Center Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • UAMS Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center
      • Moreno Valley, California, United States, 92555
        • Riverside University Health System Medical Center
      • Orange, California, United States, 92868
        • UC Irvine
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital and Trauma Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Aurora
      • Colorado Springs, Colorado, United States, 80909
        • UC Health Memorial Hospital Central
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Hospital
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32209
        • UF Health Jacksonville
      • Miami, Florida, United States, 33136
        • University of Miami/Ryder Trauma Center
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Health System
      • Macon, Georgia, United States, 31201
        • Atrium Health - Medical Center of central Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent's Hospital
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Methodist Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Albert B. Chandler Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center of New Orleans
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Health Partners Regions Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center (Ummc)
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • St Louis, Missouri, United States, 63104
        • SSM Health St. Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • UNMC (University of Nebraska Medical Center)
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health Care
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
      • Trenton, New Jersey, United States, 08638
        • Capital Health Regional Medical Center
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • Mineola, New York, United States, 11501
        • NYU Langone
      • Richmond Hill, New York, United States, 11418
        • Jamaica Hospital Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Sanford Medical Center Fargo
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Toledo, Ohio, United States, 43608
        • Mercy Health - St. Vincent Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Sciences University Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Presbyterian
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University (Rhode Island Hospital)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford USD Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Baroness Hospital
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center - UTMCK
      • Memphis, Tennessee, United States, 38103
        • Regional Medical Center
      • Nashville, Tennessee, United States, 37027
        • Vanderbilt Hospital and Clinics
    • Texas
      • Austin, Texas, United States, 78701
        • Dell Seton Medical Center
      • El Paso, Texas, United States, 79905
        • University Medical Center El Paso
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76134
        • JPS Health Network (John Peter Smith Hospital)
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital - Baylor Medical Center - Harris Health Network
      • San Antonio, Texas, United States, 78229
        • University Hospital
      • Tyler, Texas, United States, 75701
        • UT Health Tyler
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • J.W. Ruby Memorial Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With All-cause 6-hour Mortality
Time Frame: Up to 6 hours after randomization
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Up to 6 hours after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With All-cause 24-hour In-hospital Mortality
Time Frame: Up to 24 hours after randomization
In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Up to 24 hours after randomization
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization
Time Frame: Up to 30 days after randomization
In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Up to 30 days after randomization
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury
Time Frame: Up to 24 hours after randomization
Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Up to 24 hours after randomization
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time Frame: Up to 30 days after randomization
The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.
Up to 30 days after randomization
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)
Time Frame: Up to 30 days after randomization
The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke [including thromboembolic stroke], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.
Up to 30 days after randomization
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)
Time Frame: Up to 30 days after randomization
ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.
Up to 30 days after randomization
Number of Participants With Multiple Organ Failure
Time Frame: Up to 30 days after randomization
Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents "mild" and 3 was "severe". Multiple organ failure is defined as a score > 3.
Up to 30 days after randomization
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy
Time Frame: Up to 30 days after randomization
Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours
Up to 30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BE1116_3006
  • 2021-005060-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

IPD Sharing Time Frame

Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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