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

RecruitingPhase 3Ages 18 Years - 75 YearsAllAustralian and New Zealand Intensive Care Researc…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Patients with trauma admitted to the ICU who: * 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 * Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution * Have informed consent from a legal surrogate according to local law Exclusion Criteria: Patients will be excluded from the study if any of the following criteria apply: * 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 * First dose of study drug unable to be given within 24 hours of primary injury * Pregnancy or lactation or 3 months postpartum * Expected to die imminently (\< 24 hours) * Known sensitivity to mammalian cell derived products * Known contraindication to epoetin alfa * End stage renal failure (receives chronic dialysis) * Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome * The treating physician believes it is not in the best interest of the patient to be randomised to this trial
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What it tests

  • Epoetin Alfa 40000 UNT/ML
  • Sodium Chloride 0.9%
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Where

41 sites
Royal Prince Alfred Hospital
Camperdown, Australia
St Vincent's Hospital Sydney
Darlinghurst, Australia
St George Hospital
Kogarah, Australia
Liverpool Hospital
Liverpool, Australia
John Hunter Hospital
New Lambton Heights, Australia
Royal North Shore Hospital
Saint Leonards, Australia
Westmead Hospital
Westmead, Australia
Royal Darwin Hospital
Tiwi, Australia

…and 33 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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