Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- Conditions
- Traumatic Injury
- Interventions
- Drug: BE1116Drug: Placebo
- Registration Number
- NCT05568888
- Lead Sponsor
- CSL Behring
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1370
- (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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BE1116 BE1116 Administration by IV infusion Placebo Placebo Administration by IV infusion
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo Up to 30 days after randomization Number and proportion of subjects with Multiple organ failure to BE1116 or placebo Up to 30 days after randomization 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 Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm Up to 30 days after randomization In-hospital mortality will only be recorded and assessed for the primary hospitalization.
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 Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo Up to 30 days after randomization Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo Up to 30 days after randomization 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.
Trial Locations
- Locations (111)
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, District of Columbia, United States
George Washington University Hospital
🇺🇸Washington, 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
🇺🇸Madison, Wisconsin, 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
🇺🇸Saint Louis, Missouri, United States
Barnes Jewish Hospital
🇺🇸Saint 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
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
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