Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury.
Jeffrey Presneill, Lorraine Little, Alistair Nichol, Craig French, D James Cooper, Samir Haddad, Jacques Duranteau, Olivier Huet, Markus Skrifvars, Yaseen Arabi, Rinaldo Bellomo, undefined EPO-TBI Investigators, undefined ANZICS Clinical Trials Group
Trials | Published : 2014
BACKGROUND: The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes. METHODS: EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled. Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection admini..View full abstract