Clinical trial NCT05568888: Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Traumatic Injury
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 1370
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in proportion of subjects in all-cause mortality in the BE1116 arm compared with the placebo arm
timeFrame: Up to 6 hours after randomization
Secondary outcomes:
measure: Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm
timeFrame: Up to 24 hours after randomization
measure: Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm
timeFrame: Up to 30 days after randomization
measure: 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
timeFrame: Up to 24 hours after randomization
measure: Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo
timeFrame: Up to 30 days after randomization
measure: Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo
timeFrame: Up to 30 days after randomization
measure: Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo
timeFrame: Up to 30 days after randomization
measure: Number and proportion of subjects with Multiple organ failure to BE1116 or placebo
timeFrame: Up to 30 days after randomization
measure: Number and proportion of subjects with Acute kidney injury (AKI) requiring renal replacement therapy (dialysis, hemofiltration, or hemodiafiltration) to BE1116 or placebo
timeFrame: Up to 30 days after randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Valleywise Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Osborn Medical Center
state: Arizona
city: Tucson
country: United States
facility: University Medical Center Tucson
state: Arizona
city: Little Rock
country: United States
facility: UAMS Medical Center
state: Arkansas
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Moreno Valley
country: United States
facility: Riverside University Health System Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital and Trauma Center
state: California
city: Aurora
country: United States
facility: University of Colorado Aurora
state: Colorado
city: Colorado Springs
country: United States
facility: UC Health Memorial Hospital Central
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Medical Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami/Ryder Trauma Center
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Health System
state: Georgia
city: Macon
country: United States
facility: Atrium Health - Medical Center of central Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Albert B. Chandler Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center of New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Shreveport
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Health Partners Regions Hospital
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center (UMMC)
state: Mississippi
city: Saint Louis
country: United States
facility: SSM Health St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: UNMC (University of Nebraska Medical Center)
state: Nebraska
city: Camden
country: United States
facility: Cooper Health Care
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Trenton
country: United States
facility: Capital Health Regional Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Mineola
country: United States
facility: NYU Langone
state: New York
city: Richmond Hill
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center Fargo
state: North Dakota
city: Akron
country: United States
facility: Summa Health System - Akron Campus
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Brown University (Rhode Island Hospital)
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Baroness Hospital
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center - UTMCK
state: Tennessee
city: Memphis
country: United States
facility: Regional Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Hospital and Clinics
state: Tennessee
city: Austin
country: United States
facility: Dell Seton Medical Center
state: Texas
city: El Paso
country: United States
facility: University Medical Center El Paso
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network (John Peter Smith Hospital)
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital - Baylor Medical Center - Harris Health Network
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: San Antonio
country: United States
facility: University Hospital
state: Texas
city: Tyler
country: United States
facility: UT Health Tyler
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Morgantown
country: United States
facility: J.W. Ruby Memorial Hospital
state: West Virginia
city: Madison
country: United States
facility: University Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Sydney
country: Australia
facility: Liverpool Hospital
state: Liverpool
city: Sydney
country: Australia
facility: John Hunter Hospital
state: New Lambton
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide
state: South Australia
city: Kogarah
country: Australia
facility: St. George Hospital
state: Sydney
city: Westmead
country: Australia
facility: Westmead Hospital
state: Sydney
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge Addenbrookes University
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: London
country: United Kingdom
facility: St. Georges Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: