Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- Conditions
- Traumatic Injury
- Registration Number
- NCT05568888
- Lead Sponsor
- CSL Behring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8000
Inclusion Criteria:<br><br> - (a) Estimated age = 15 years. Older minimum age is required in some locations. FOR<br> United Kingdom: Estimated or actual age = 16 years FOR Australia: Estimated or<br> actual age = 18 years AND (b) Estimated or actual weight = 50 kg (110 lbs).<br><br> - Traumatic injury with confirmed or suspected acute major bleeding and/or Revised<br> Assessment of Bleeding and Transfusion (RABT) score = 2<br><br> - Activation of massive transfusion protocol<br><br>Exclusion Criteria:<br><br> - Healthcare professional cardiopulmonary resuscitation including chest compressions<br> for = 5 consecutive minutes at any time before randomization<br><br> - Isolated penetrating or blunt cranial injury, or exposed brain matter<br><br> - Isolated burns estimated to be > 20% total body surface area or suspected<br> inhalational injury<br><br> - Known anticoagulation treatment or a history of a TEE, within the past 3 months.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in proportion of subjects in all-cause mortality in the BE1116 arm compared with the placebo arm
- Secondary Outcome Measures
Name Time Method Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm;Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm;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;Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo;Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo;Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo;Number and proportion of subjects with Multiple organ failure to BE1116 or placebo;Number and proportion of subjects with Acute kidney injury (AKI) requiring renal replacement therapy (dialysis, hemofiltration, or hemodiafiltration) to BE1116 or placebo