EPO-TBI: Erythropoietin in Traumatic Brain Injury
The EPO-TBI Study is a stratified, prospective, multi-centre, randomised, double-blind, placebo-controlled, phase III trial in intensive care unit (ICU) patients with moderate or severe traumatic brain injury (TBI) to determine whether erythropoietin (EPO) improves neurological function 6 months after injury. This study will be conducted in Australia, New Zealand, the Kingdom of Saudi Arabia, France, Finland and Singapore.
Goal: This trial will determine whether EPO therapy is effective and safe in TBI. If EPO is proven to improve neurological outcomes and is introduced clinically, given the high disability rate and high mortality rate, at least 150 patients may have significantly improved neurological outcomes per year in our country by the widespread application of EPO. To change only a few of these patients from an unfavourable to a favourable neurological outcome would alone result in lifetime dollar savings. This study, aimed at objectively resolving the uncertainty about EPO in ICU patients with moderate and severe TBI, is of the highest priority.
Rationale: Traumatic brain injury (TBI) is a catastrophic illness with extraordinary human and financial costs. There is substantial experimental evidence, a plausible biological rationale, and supportive clinical evidence from clinical trials to suggest a possible beneficial effect of EPO in TBI. Clinical practice is changing in the USA, prematurely leading to a loss of equipoise despite inconclusive data. There is concern that the use of EPO may increase thrombosis in critically ill patients and there are no trials with adequate methodology to study both efficacy and risks of EPO in TBI patients. The significance and cost of TBI, the possible benefits, the growing off-label use, the concern about side effects of EPO, and the lack of direct evidence of benefit make a trial of the highest quality essential to guide future clinical practice.
Study Progress: Patient recruitment commenced in May 2010.
Endorsement: The EPO-TBI Study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG).
Funding: The EPO-TBI Study is funded by project grants from the National Health and Medical Research Council (NHMRC) and the Victorian Neurotrauma Initiative (VNI).
Contact: For further information about this study, please contact the ANZIC-RC EPO-TBI Study Project Manager, Lorraine Little, by email.
Data Entry Website: https://epo-tbi.anzicrc.monash.org