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New treatment option for Trauma
Official title ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
ClinicalTrials.gov ID: NCT04588311
What this study is testing
What is Epoetin Alfa 40000 UNT/ML?
Epoetin Alfa 40000 UNT/ML is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for trauma.
Also referred to as Eprex, Binocrit.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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 assigned by chance to this trial
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Liverpool, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Saint Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Tiwi, Northern Territory, Australia
- Cairns, Queensland, Australia
- Herston, Queensland, Australia
- Southport, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Brussels, Belgium
- Charleroi, Belgium
- Genk, Belgium
- Ghent, Belgium
- Liège, Belgium
+ 18 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Darlinghurst, New South Wales, Australia; Kogarah, New South Wales, Australia; Liverpool, New South Wales, Australia; New Lambton Heights, New South Wales, Australia; Saint Leonards, New South Wales, Australia and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.