A prospective, multicentre, randomised, double-blind placebo-controlled, phase III trial of EPOetin alfa vs, placebo in critically ill TRAUMA patients
Trauma-a major public health problem
Trauma is a global health problem with estimates of more than five million deaths per year (WHO). Trauma includes road traffic accidents, falls, assaults and crush injuries. Patients who suffer major trauma are often critically ill and require breathing support. Despite aggressive treatment in an intensive Care Unit (ICU), many patients still die and many survivors have a long-term disability. The majority of these patients are of working age (16-64). This has a huge impact on patients, their families and society as a whole.
This study will test whether additional ‘erythropoietin’ (EPO for short, a human hormone) given to major trauma patients within 24 hours of hospital admission reduces patient death and/or disability. The study will compare outcomes between two groups; A) a patient group receiving standard care and EPO and B) a patient group receiving standard care alone.
When the body suffers trauma the immune system responds to help. However, the immune system often over-responds which can actually lead to further tissue damage. EPO helps to minimise this over-response and also encourages tissue healing.
Although previous studies indicate that EPO may reduce death and disability in trauma patients, there is not enough evidence at present to include EPO in standard treatment. This study will address the role of EPO in the care of major trauma patients in ICU.
Why this group?
The Irish Critical Care-Clinical Trial Network, including our EPO-TRAUMA sites in Europe, the Middle East, Australia and New Zealand is uniquely placed to successfully deliver this study.
If this study shows that EPO works, survival rates of future major trauma patients will improve in Ireland and globally, and fewer survivors will develop a long-term disability. This will result in huge societal benefits.
- Award Date
- 07 March 2019
- Award Value
- Principal Investigator
- Professor Alistair Nichol
- Host Institution
- University College Dublin
- DIFA 2018