title: Intracranial pressure monitoring in severe traumatic brain injury in latin america: process and methods for a multi-center randomized controlled trial.
abstract: In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns.
authors.affiliation: Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, Oregon 97239, USA. carneyn@ohsu.edu
authors.forename: Nancy
authors.initials: N
authors.lastname: Carney
authors.forename: Silvia
authors.initials: S
authors.lastname: Lujan
authors.forename: Sureyya
authors.initials: S
authors.lastname: Dikmen
authors.forename: Nancy
authors.initials: N
authors.lastname: Temkin
authors.forename: Gustavo
authors.initials: G
authors.lastname: Petroni
authors.forename: Jim
authors.initials: J
authors.lastname: Pridgeon
authors.forename: Jason
authors.initials: J
authors.lastname: Barber
authors.forename: Joan
authors.initials: J
authors.lastname: Machamer
authors.forename: Mariana
authors.initials: M
authors.lastname: Cherner
authors.forename: Kelley
authors.initials: K
authors.lastname: Chaddock
authors.forename: Terence
authors.initials: T
authors.lastname: Hendrix
authors.forename: Carlos
authors.initials: C
authors.lastname: Rondina
authors.forename: Walter
authors.initials: W
authors.lastname: Videtta
authors.forename: Juanita M
authors.initials: JM
authors.lastname: Celix
authors.forename: Randall
authors.initials: R
authors.lastname: Chesnut
mesh_terms: D001838:Bolivia; D001930:Brain Injuries / Q000150:complications*; D006801:Humans; D019586:Intracranial Hypertension / Q000175:diagnosis* / Q000209:etiology* / Q000628:therapy; D007427:Intracranial Pressure / Q000502:physiology; D008991:Monitoring, Physiologic; D020127:Recovery of Function; D012107:Research Design