Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment
This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of ventilator-free days at 28 days.
Acute onset of respiratory failure within 1 week of a known clinical insult or n... [+9]
Pregnant or lactating women, or positive/indeterminate pregnancy test (serum or... [+14]