Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| 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 € |
Trial team
| 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 |
DOCUMENTS
References
Funding scheme
