ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
Recruiting
Phase 3
Interventional Study
Trauma
Traumatic Injury
Traumatic Brain Injury
Wounds and Injuries
Penetrating Injury
Blunt Injury
Major Trauma
Multiple Trauma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,500 (estimated)
- Sponsor
- Australian and New Zealand Intensive Care Research Centre · Other
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About This Trial
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 fr…
Trial Locations
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Eligibility 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 applicab…
Contacts