Using Erythropoietin Alfa to Improve Outcomes in Critically Ill Trauma Patients
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury
This study is testing if a medication called epoetin alfa can help critically ill trauma patients recover better and reduce the risk of death or severe disability.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre Academic / other |
| Locations | 41 sites (Camperdown, New South Wales and 40 other locations) |
| Trial ID | NCT04588311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have sustained a primary traumatic injury and are invasively mechanically ventilated within 24 hours of injury.
Not a fit: Patients with severe neurological impairment, recent thromboembolic events, or those expected to die imminently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and long-term disability in critically ill trauma patients.
How similar studies have performed: Previous studies have indicated potential benefits of erythropoietin in trauma care, but this specific approach is being tested in a large-scale, controlled setting for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Camperdown, New South Wales and 40 other locations
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Active_not_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)
- Royal Darwin Hospital — Tiwi, Northern Territory, Australia (Not_yet_recruiting)
- Cairns Hospital — Cairns, Queensland, Australia (Withdrawn)
- Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (Recruiting)
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Adelaide, South Australia, Australia (Not_yet_recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Not_yet_recruiting)
- HUB Hopital Erasme — Brussels, Belgium (Not_yet_recruiting)
- CHU-Charleroi Chimay — Charleroi, Belgium (Recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Not_yet_recruiting)
- Ghent University Hospital — Ghent, Belgium (Not_yet_recruiting)
- CHR de la Citadelle de LIEGE — Liège, Belgium (Not_yet_recruiting)
- Helsinki University Hospital (HUS) — Helsinki, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- University Hospital Münster — Münster, Germany (Recruiting)
- Beaumont Hospital — Beaumont, Ireland (Recruiting)
- Cork University Hospital — Cork, Ireland (Recruiting)
- St Vincent's University Hospital — Dublin, Ireland (Recruiting)
- Auckland City Hospital — Grafton, Auckland, New Zealand (Recruiting)
- Christchurch Hospital — Christchurch, Christchurch, New Zealand (Recruiting)
- Middlemore Hospital — Auckland, Otahuhu, New Zealand (Recruiting)
- Waikato Hospital — Hamilton, Waikato Region, New Zealand (Recruiting)
- Wellington Hospital — Newtown, Wellington Region, New Zealand (Recruiting)
- King Abdulaziz Medical City — Riyadh, Saudi Arabia (Recruiting)
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
- University Medical Centre Maribor — Maribor, Slovenia (Recruiting)
- University Hospital Bern — Bern, Switzerland (Recruiting)
- Lucerne Cantonal Hospital — Lucerne, Switzerland (Not_yet_recruiting)
- St. Gallen Cantonal Hospital — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Study coordinator: Vicki Papanikolaou
- Email: vicki.papanikolaou@monash.edu
- Phone: +61 409 142 695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.