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

Study acronym: EPO-TRAUMA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study sites: 34 to 41
    • Study completion date: Dec 31, 2025 to Aug 31, 2027
    v10
  2. Site details revised at 1 of 34 sitesv9
  3. Study sites: 35 to 34v8
  4. Study sites: 34 to 35v7
  5. Site details revised at 5 of 34 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2025
    • Study sites: 20 to 34
    v5
  2. Study sites: 19 to 20v4
  3. Study sites: 17 to 19v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2020 to Nov 9, 2020
    • Site details revised at 17 of 17 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.
Trial Details
NCT Number NCT04588311
Lead Sponsor Australian and New Zealand Intensive Care Research Centre
Collaborators: University College Dublin, Medical Research Institute of New Zealand, Medical Research Future Fund, Health Research Board, Ireland, Health Research Council, New Zealand, Irish Critical Care Clinical Trials Network, ANZICS Clinical Trials Group, Monash University
Conditions
(from sponsor)		 Trauma, Traumatic Injury, Traumatic Brain Injury, Wounds and Injuries, Penetrating Injury, Blunt Injury, Major Trauma, Multiple Trauma
Related terms Brain Injuries, Traumatic, Multiple Trauma, Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov