ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Oct 8, 2020

Keywords

ClinConnect Summary

The EPO-TRAUMA study is a clinical trial designed to see if a medication called epoetin alfa can help critically ill trauma patients live longer and reduce serious disabilities after their injuries. This study will involve about 2,500 patients who are in the intensive care unit (ICU) and have experienced significant trauma, such as severe injuries from accidents. Participants will be randomly assigned to receive either epoetin alfa or a placebo (a harmless substance with no active medication) and will be monitored for six months to see how they recover.

To join this study, patients must be between 18 and 75 years old, have been injured within the last 24 hours, and need to be on a ventilator in the ICU. They should also be expected to stay in the ICU for at least two days. However, there are some reasons why someone might not be eligible to participate, such as having a severe brain injury, recent blood clots, or certain health conditions. If eligible, participants will receive either the medication or placebo, and their recovery will be assessed over time. This trial is important because it could lead to new treatments that help improve outcomes for trauma patients.

Gender

ALL

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 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