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

Traumatic Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568888
• Other study ID #: BE1116_3006
• Secondary ID: 2021-005060-21
• Status: Recruiting
• Phase: Phase 3
• Start date: March 28, 2023
• Est. completion date: September 2026

Study information

• Verified date: June 2024
• Source: CSL Behring
• Contact: Trial Registration Coordinator
• Phone: +1 610-878-4000
• Email: clinicaltrials[@]cslbehring.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• BE1116
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
• Placebo
Administered by IV infusion

Locations

Country	Name	City	State
Australia	Royal Adelaide	Adelaide	South Australia
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	St. George Hospital	Kogarah	Sydney
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	John Hunter Hospital	Sydney	New Lambton
Australia	Liverpool Hospital	Sydney	Liverpool
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	Sydney
United Kingdom	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	Imperial College Healthcare	London
United Kingdom	St. Georges Hospital	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 States	Summa Health System - Akron Campus	Akron	Ohio
United States	University Hospital	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	University of Colorado Aurora	Aurora	Colorado
United States	Dell Seton Medical Center	Austin	Texas
United States	UAB Hospital	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Erie County Medical Center	Buffalo	New York
United States	Cooper Health Care	Camden	New Jersey
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Erlanger Baroness Hospital	Chattanooga	Tennessee
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	UC Health Memorial Hospital Central	Colorado Springs	Colorado
United States	The Ohio State University	Columbus	Ohio
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	University Medical Center El Paso	El Paso	Texas
United States	Sanford Medical Center Fargo	Fargo	North Dakota
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	JPS Health Network (John Peter Smith Hospital)	Fort Worth	Texas
United States	Northeast Georgia Health System	Gainesville	Georgia
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Ben Taub General Hospital - Baylor Medical Center - Harris Health Network	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
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	University of Mississippi Medical Center (UMMC)	Jackson	Mississippi
United States	UF Health Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Tennessee Medical Center - UTMCK	Knoxville	Tennessee
United States	University of Kentucky Albert B. Chandler Hospital	Lexington	Kentucky
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	University of Louisville Hospital	Louisville	Kentucky
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Atrium Health - Medical Center of central Georgia	Macon	Georgia
United States	University Hospital	Madison	Wisconsin
United States	Regional Medical Center	Memphis	Tennessee
United States	University of Miami/Ryder Trauma Center	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	NYU Langone	Mineola	New York
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of South Alabama	Mobile	Alabama
United States	Riverside University Health System Medical Center	Moreno Valley	California
United States	J.W. Ruby Memorial Hospital	Morgantown	West Virginia
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt Hospital and Clinics	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	University Medical Center of New Orleans	New Orleans	Louisiana
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	UNMC (University of Nebraska Medical Center)	Omaha	Nebraska
United States	UC Irvine	Orange	California
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Valleywise Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Presbyterian	Pittsburgh	Pennsylvania
United States	Oregon Health and Sciences University Hospital	Portland	Oregon
United States	Brown University (Rhode Island Hospital)	Providence	Rhode Island
United States	Jamaica Hospital Medical Center	Richmond Hill	New York
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	UC Davis Medical Center	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	SSM Health St. Louis	Saint Louis	Missouri
United States	Health Partners Regions Hospital	Saint Paul	Minnesota
United States	University of Utah Hospital	Salt Lake City	Utah
United States	University Hospital	San Antonio	Texas
United States	UC San Diego Medical Center	San Diego	California
United States	San Francisco General Hospital and Trauma Center	San Francisco	California
United States	HonorHealth Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	Harborview Medical Center	Seattle	Washington
United States	LSU Health Shreveport	Shreveport	Louisiana
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Mercy Health - St. Vincent Medical Center	Toledo	Ohio
United States	Capital Health Regional Medical Center	Trenton	New Jersey
United States	University Medical Center Tucson	Tucson	Arizona
United States	UT Health Tyler	Tyler	Texas
United States	George Washington University Hospital	Washington	District of Columbia
United States	MedStar Washington Medical Center	Washington	District of Columbia
United States	Reading Hospital	West Reading	Pennsylvania
United States	Wake Forest Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in proportion of subjects in all-cause mortality in the BE1116 arm compared with the placebo arm		Up to 6 hours after randomization
Secondary	Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm	In-hospital mortality will only be recorded and assessed for the primary hospitalization.	Up to 24 hours after randomization
Secondary	Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm	In-hospital mortality will only be recorded and assessed for the primary hospitalization.	Up to 30 days after randomization
Secondary	Difference in proportion of subjects who undergo surgical or interventional radiological procedures to stop bleeding related to the primary injury in the BE1116 arm compared with the placebo arm		Up to 24 hours after randomization
Secondary	Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo		Up to 30 days after randomization
Secondary	Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo	Thromboembolic events (TEEs), symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke [including thromboembolic stroke], myocardial infarction). Superficial thromboses will not be included as adverse events of special interest.	Up to 30 days after randomization
Secondary	Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo		Up to 30 days after randomization
Secondary	Number and proportion of subjects with Multiple organ failure to BE1116 or placebo		Up to 30 days after randomization
Secondary	Number and proportion of subjects with Acute kidney injury (AKI) requiring renal replacement therapy (dialysis, hemofiltration, or hemodiafiltration) to BE1116 or placebo		Up to 30 days after randomization