A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury

ANZIC-RC/CF001

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.

2020-11-09

2025-12-31

2025-12-31

Recruiting

Early phase I

2500

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2500, 'type': 'ESTIMATED'}}

2023-10-03