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.
Are ≥ 18 to ≤ 75 years of age
Are < 24 hours since primary traumatic injury
Are invasively mechanically ventilated
Are expected to stay in the ICU ≥ 48 hours
GCS = 3 and fixed dilated pupils
Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)
A chronic hypercoagulable disorder, including known malignancy
Treatment with EPO in the last 30 days
Parallel
Epoetin Alfa 40000 UNT/ML
DrugEpoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
Sodium Chloride 0.9%
DrugSodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25)
Mortality at 6-months
Mortality at ICU discharge
Mortality at Hospital discharge
Mortality at day 28
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Australian and New Zealand Intensive Care Research Centre
Lead sponsor
University College Dublin
Collaborator
Medical Research Institute of New Zealand
Collaborator
Medical Research Future Fund
Collaborator
Health Research Board, Ireland
Collaborator
Health Research Council, New Zealand
Collaborator
Irish Critical Care Clinical Trials Network
Collaborator
ANZICS Clinical Trials Group
Collaborator
Monash University
Collaborator
