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
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring |
United States, Australia, United Kingdom,
| 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 |
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