Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Healios Investigational Site
Houston, Texas, United States
RECRUITINGA composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)
Time frame: Day 30
Mortality
mortality including median time to death within the acute hospitalization period
Time frame: Day 30, Day 90, Day 365
Incidence of Acute Kidney Injury adjusted for the competing risk of death
Time frame: Day 30
Incidence of sepsis, Acute Respiratory Distress Syndrome, Multiple Organ Failure, and Venous Thromboembolism
Time frame: Day 30
Hospital days
Free days will be defined as the number of days an individual was alive and not in the hospital.
Time frame: Day 30
ICU days
Free days will be defined as the number of days an individual was alive and not in the ICU.
Time frame: Day 30
ventilator-free days
Free days will be defined as the number of days an individual was alive and not on the ventilator.
Time frame: Day 30
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