Intracranial pressure monitoring in severe traumatic brain injury in Latin America: Process and methods for a multi-center randomized controlled trial

Nancy Carney, Silvia Lujan, Sureyya Dikmen, Nancy Temkin, Gustavo Petroni, Jim Pridgeon, Jason Barber, Joan MacHamer, Mariana Cherner, Kelley Chaddock, Terence Hendrix, Carlos Rondina, Walter Videtta, Juanita M. Celix, Randall Chesnut

Research output: Contribution to journalArticle

14 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2022-2029
Number of pages8
JournalJournal of neurotrauma
Volume29
Issue number11
DOIs
StatePublished - Jul 20 2012

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Keywords

  • international
  • intracranial pressure monitoring
  • randomized controlled trial
  • traumatic brain injury

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Carney, N., Lujan, S., Dikmen, S., Temkin, N., Petroni, G., Pridgeon, J., Barber, J., MacHamer, J., Cherner, M., Chaddock, K., Hendrix, T., Rondina, C., Videtta, W., Celix, J. M., & Chesnut, R. (2012). Intracranial pressure monitoring in severe traumatic brain injury in Latin America: Process and methods for a multi-center randomized controlled trial. Journal of neurotrauma, 29(11), 2022-2029. https://doi.org/10.1089/neu.2011.2019