title: Traumatic brain injury in Latin America: lifespan analysis randomized control trial protocol*.
abstract: BACKGROUND
  Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously.
  
  
  OBJECTIVE
  The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies.
  
  
  METHODS
  Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers.
  
  
  OBJECTIVE
  There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay.
  
  
  CONCLUSIONS
  This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
authors.affiliation: Department of Neurological Surgery, University of Washington, Harborview Medical Center, Seattle, Washington 98104, USA. chesnutr@uw.edu
authors.forename: Randall M
authors.initials: RM
authors.lastname: Chesnut
authors.forename: Nancy
authors.initials: N
authors.lastname: Temkin
authors.forename: Nancy
authors.initials: N
authors.lastname: Carney
authors.forename: Sureyya
authors.initials: S
authors.lastname: Dikmen
authors.forename: Jim
authors.initials: J
authors.lastname: Pridgeon
authors.forename: Jason
authors.initials: J
authors.lastname: Barber
authors.forename: Juanita M
authors.initials: JM
authors.lastname: Celix
authors.forename: Kelley
authors.initials: K
authors.lastname: Chaddock
authors.forename: Marianna
authors.initials: M
authors.lastname: Cherner
authors.forename: Terence
authors.initials: T
authors.lastname: Hendrix
authors.forename: Silvia
authors.initials: S
authors.lastname: Lujan
authors.forename: Joan
authors.initials: J
authors.lastname: Machamer
authors.forename: Gustavo
authors.initials: G
authors.lastname: Petroni
authors.forename: Carlos
authors.initials: C
authors.lastname: Rondina
authors.forename: Walter
authors.initials: W
authors.lastname: Videtta
mesh_terms: D000328:Adult; D000368:Aged; D001930:Brain Injuries / Q000453:epidemiology* / Q000628:therapy*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007427:Intracranial Pressure / Q000502:physiology; D007843:Latin America / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009483:Neuropsychological Tests; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016896:Treatment Outcome