Using Erythropoietin Alfa to Improve Outcomes in Critically Ill Trauma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EPO-TRAUMA study is a phase III, multi-centre, double-blind, randomized controlled trial that evaluates the effectiveness of epoetin alfa in reducing mortality and severe disability among critically ill trauma patients. The study will recruit 2500 mechanically ventilated patients admitted to the ICU with a primary trauma diagnosis across various centers in Australia, New Zealand, Europe, and Saudi Arabia. Participants will receive either epoetin alfa or a placebo within 24 hours of their injury, and their outcomes will be assessed at six months post-injury. The trial aims to explore the protective effects of erythropoietin beyond its role in red blood cell production.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• John Hunter Hospital
  New Lambton Heights, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  Saint Leonards, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Vicki Papanikolaou
• Email: vicki.papanikolaou@monash.edu
• Phone: +61 409 142 695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.