Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- 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
Scroll for more (101 remaining)UAB Hospital🇺🇸Birmingham, Alabama, United States