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

Phase 3 Recruiting 2500 enrolled Australian and New Zealand Intensive Care Research Centre ANZICS Clinical Trials Group · collab Health Research Board, Ireland · collab Health Research Council, New Zealand · collab Irish Critical Care Clinical Trials Network · collab Medical Research Future Fund · collab Medical Research Institute of New Zealand · collab Monash University · collab University College Dublin · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2020-11-09
Primary completion: 2026-12-31
Completion: 2027-08-31

Publications

Results Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	epoetin alfa	Protein / enzyme biologic	40000 iu	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications