• J Hutchison, R Ward, J Lacroix, P Hébert, P Skippen, M Barnes, P Meyer, K Morris, H Kirpalani, R Singh, P Dirks, D Bohn, D Moher, HyP-HIT Investigators, and Canadian Critical Care Trials Group.
• Department of Critical Care Medicine, Hospital for Sick Children, and Interdepartmental Division of Critical Care, Faculty of Medicine, University of Toronto, Canada. Jamie.Hutchison@sickkids.ca
• Dev. Neurosci. 2006 Jan 1;28(4-5):291-301.

BackgroundThe utility of a pretrial clinical evaluation or run-in phase prior to conducting trials of complex interventions such as hypothermia therapy following severe traumatic brain injury in children and adolescents has not been established.MethodsThe primary objective of this study was to prospectively evaluate the ability of investigators to adhere to the clinical protocols of care including the cooling and rewarming procedures as well as management guidelines in patients with severe traumatic brain injury (Glasgow Coma ScaleResultsSeventeen of the 18 centers completed the pretrial clinical evaluation phase demonstrating compliance with study procedures and proceeded to an RCT of hypothermia therapy. One center enrolled only 1 patient in the pretrial clinical evaluation phase due to small numbers of patients with traumatic brain injury, and therefore, did not proceed to the RCT. Three centers were required to enroll more than 2 patients in the pretrial clinical evaluation phase prior to proceeding to the RCT because of problems with adherence to the clinical protocols at two centers and the training of new study personnel at another center. Of the 39 patients enrolled during the pretrial clinical evaluation phase, 8 (20.5%) died and 22 (62.9%) had a good outcome defined as normal, mild or moderate disability assessed using the Pediatric Cerebral Performance Category score at 6 months following injury.DiscussionThe pretrial clinical evaluation phase was useful to ensure compliance with complex hypothermia therapy and consensus-based clinical management guidelines of care successfully implemented across 17 of 18 centers. This study maneuver allowed us to complete a subsequent RCT in 225 children following severe traumatic brain injury.Copyright (c) 2006 S. Karger AG, Basel.

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