A randomised controlled trial of ErythroPOietin in Trauma.

Aims: The primary aim of this trial is to evaluate the effect of epoetin alfa compared to placebo, administered to critically ill, mechanically ventilated, trauma patients on mortality and severe disability.

Rationale: Traumatic injury is a global disease with extraordinary human and financial costs. There is substantial evidence, a plausible biological rationale, and supportive evidence from clinical trials to suggest a possible beneficial effect of EPO in critically ill trauma patients. However, as yet in Australia and New Zealand practise has not yet changed to routinely incorporate EPO in critically ill trauma patients. The significance and cost of traumatic injury, the possible benefits of EPO, the potential for growing off-label use, and the lack of direct evidence of benefit make a trial of the highest quality essential to guide future clinical practice.

Study Progress: The study has been reviewed and approved by the Melbourne Health Human Research Ethics Committee (HREC/59445/MH-2019). Participant recruitment commenced in November 2020. Keep up to date with our progress and study updates on Twitter @EPO_Trauma

Trial Registration: This study has been registered with the Australian New Zealand Clinical Trials Registry. ACTRN12619001632189p

Endorsement: The study has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG) CTG1617-005.

Further information and Data Entry/CRF: https://www.epotrauma.org/

Contact: For further information about this study, please contact the EPO-TRAUMA Chief Investigators, A/Prof Craig French and Prof Alistair Nichol, or the EPO-TRAUMA Project Manager, Vicki Papanikolaou by email.

Associate Professor Craig French Professor Alistair Nichol Vicki Papanikolaou