Journal article
Erythropoietin in traumatic brain injury: Study protocol for a randomised controlled trial
A Nichol, C French, L Little, J Presneill, DJ Cooper, S Haddad, J Duranteau, O Huet, M Skrifvars, Y Arabi, R Bellomo
Trials | BMC | Published : 2015
Open access
Abstract
Background: Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis. Methods/design: The erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine wheth..
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Awarded by National Health and Medical Research Council
Funding Acknowledgements
EPO-TBI is funded by the Australian National Health and Medical Research Council Project (project grant ID 545901), and the Victorian Transport Accident Commission (project grant ID D162 - formerly, the Victorian Neurotrauma Initiative). The cost of Epoetin alfa was reimbursed to hospital pharmacy departments by using project grant funds. Neither funding agencies nor the manufacturer of Epoetin alfa had any role in the trial design, data collection or analysis. EPO-TBI trial is coordinated by the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University, Melbourne, Australia and endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) and the Irish Critical Care Trials Group. The members of Management Committee are listed in Appendix 3