CLINICAL TRIAL WITH APROTININ IN THE ACUTE RESPIRATORY DISTRESS SYNDROME TREATMENT
Status:
NOT_YET_RECRUITING
Trial end date:
2030-03-01
Target enrollment:
Participant gender:
Summary
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 mortality and ventilator-free days at 28 days.
Phase:
PHASE3
Details
Lead Sponsor:
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion