Goal

The EPO-TRAUMA trial is a multi-centre, stratified, double-blind, randomised, placebo-controlled trial of erythropoietin alfa versus placebo in mechanically ventilated critically ill patients following traumatic injury. The primary aim of the study is to determine the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients.

Rationale

Traumatic injury is a global disease with extraordinary human and financial costs. There is substantial experimental 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, New Zealand, and other countries globally, 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.

This trial will determine whether EPO therapy is effective and safe in traumatic injury. It will resolve the uncertainty about EPO in critically ill trauma patients and is of the highest priority.

Overview

Prospective, multi-centre, double-blind, phase III, randomised controlled trial
2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis
Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months
Dichotomised Glasgow Outcome Score Extended (GOSE) into favourable (i.e. > 4) and unfavourable (i.e. < 4) outcomes at six months
Proportion of participants with composite thrombotic vascular events at six months
Health economic analysis

Funding

Medical Research Futures Fund - Rare Cancers Rare Diseases and Unmet Need Clinical Trials Program (MRF1170001)
Health Research Board Ireland (DIFA-2018-028)
Health Research Council of New Zealand (20/366)

Endorsement

This study is endorsed by the Australia and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) and the Irish Critical Care Clinical Trials Group (ICC-CTG).

Registration