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| Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial |
Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial
David O Okonkwo, Lori A Shutter, Carol Moore, Nancy R Temkin, Ava M Puccio, Christopher J Madden, Norberto Andaluz, Randall M Chesnut, M Ross Bullock, Gerald A Grant, John McGregor, Michael Weaver, Jack Jallo, Peter D LeRoux, Dick Moberg, Jason Barber, Christos Lazaridis, Ramon R Diaz-Arrastia
Abstract
Objectives: A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whether a neurocritical care management protocol could improve brain tissue oxygenation levels in patients with severe traumatic brain injury and the feasibility of a Phase III efficacy study.
