A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury

What this Trial Is About

Researchers are evaluating epoetin alfa, a medication related to erythropoiesis stimulating agents, in critically ill trauma patients who require mechanical ventilation in intensive care units (ICUs). This phase III, randomized, double-blind trial aims to see if epoetin alfa can reduce death rates and severe disability six months after injury. The study involves 2500 patients admitted to ICUs with primary trauma diagnoses from centers in Australia, New Zealand, Europe, and Saudi Arabia. Participants will receive either epoetin alfa 40,000 IU or a placebo (sodium chloride 0.9%) by subcutaneous injection on Study Days 1 and 8 while in the ICU. Treatment is administered during their ICU stay, and patients are randomly assigned to one of these two groups. The study is designed to compare the effects of epoetin alfa against placebo in this critically ill population. During the study, patients will be monitored for survival and disability outcomes using tools like the World Health Organization Disability Assessment Schedule (WHODAS 2.0) at six months. Other outcomes include mortality at different time points and thrombotic vascular events. Data on clinical status, adverse events, and safety will also be collected. The total participation length includes ICU stay and follow-up assessments up to six months after injury.

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients