The World Health Organization (WHO) has forecast that, by 2030, trauma will become the third leading cause of disability and death globally. Erythropoietin (EPO or epoetin) is a hormone that is essential for red blood cell production. Erythropoietin has many effects beyond increasing red blood cell numbers. Studies in animals have demonstrated the potential protective effects of EPO in organs including the brain, kidney, liver and heart and anti-inflammatory properties.
Previous research suggests that the use of epoetin alfa, a drugs with a similar function as EPO, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive.
This finding may have important implications for patient management.
In this international multicentre trial, 2500 critically ill mechanically ventilated trauma patients in Australia, New Zealand, Europe, and Saudi Arabia will be included to test if epoetin alfa compared to placebo, will reduce mortality and severe disability six months after the trauma.
| Title | ErythroPOietin alfa to prevent mortality and reduce severe disability in critically ill TRAUMA patients: a multi-centre, stratified, double-blind, randomised, placebo-controlled trial. (The EPO-TRAUMA trial) |
| Participants (P) | Mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from the participating study centres in Australia, New Zealand, Europe, and Saudi Arabia. |
| Intervention (I) | Epoetin alfa 40,000 IU/1ml subcutaneous injection administered within 24 hours of primary injury and again on day 8 (if still in ICU) |
| Control (C) | Matching Placebo (Sodium Chloride 0.9% 1ml subcutaneous injection) |
| Outcome (O) | Primary outcome: Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months |
| Trial Design | Prospective, multi-centre, double-blind, phase III, randomised controlled trial |
| Sample Size | 2 500 patients worldwide (200 patients in BE) |
| Trial duration | 37 months (54 months at international level) |
| Budget | 770 000 € |
| Sponsor | University College Dublin, Belfield, Dublin 4, Ireland Monash University, Melbourne, Vic 3004, Australia Belgian Coordinating Centre: Hôpital Erasme (HUB) |
| Chief Investigator | Prof Dr Fabio Taccone |
| Number of participating sites | 7 |
