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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,366
Proportion of Participants With All-cause 6-hour Mortality
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 6 hours after randomization
Proportion of Participants With All-cause 24-hour In-hospital Mortality
In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 24 hours after randomization
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization
In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 30 days after randomization
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury
Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 24 hours after randomization
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 103 more locations
Time frame: Up to 30 days after randomization
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)
The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke \[including thromboembolic stroke\], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.
Time frame: Up to 30 days after randomization
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)
ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.
Time frame: Up to 30 days after randomization
Number of Participants With Multiple Organ Failure
Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents "mild" and 3 was "severe". Multiple organ failure is defined as a score \> 3.
Time frame: Up to 30 days after randomization
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy
Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours
Time frame: Up to 30 days after randomization