In Low-to-Middle Income Countries (LMICs), the probability of death for patients sustaining a severe trauma, including traumatic brain injury (TBI), is two to six times greater than for patients in High Income Countries (HICs). This disparity is associated with lower levels of technical resources, including monitoring of intracranial pressure (ICP). A main risk factor for death and disability in severe TBI (sTBI) patients is increased ICP due to brain swelling. Decompressive craniectomy (DC) is a neurosurgical procedure in which a large portion of the skull is removed to allow more space for a swelling brain to expand without further increasing ICP. The evidence- based treatment options in The Guidelines for the Management of Severe Traumatic Brain Injury rely on ICP monitoring to know when and how to intervene. An important question, yet unanswered, is whether, and in which patients, DC should be performed early (within 6-12 hours post-injury), or delayed (12 to 48 hours post-injury, and after Intensive Care Unit [ICU] medical treatment fails). Currently, several randomized controlled trials (RCTs) are being conducted to answer that question, but unfortunately, only in patients who have ICP monitoring. However, most of the developing world does not have access to ICP monitors. Thus, there is a need for standardized approaches to clinical assessment of TBI in environments without ICP monitors, and for the identification of effective, low-cost, protocol-driven interventions for treatment as well as to create of capacity to conduct research about TBI. Colombia, a country with a very high incidence of TBI, has a health infrastructure ready to facilitate capacity building for neurotrauma clinical research. We propose to develop capacity for ongoing neurotrauma research in Colombia, by conducting a pilot study in three trauma centers in which we will develop and introduce an algorithm for the care of sTBI patients. The algorithm will consist of a checklist for selection of patients for early DC and a protocol for their inter- and post-operative care. We will compare outcomes for sTBI patients treated before and after the introduction of the algorithm, which will provide preliminary data to support an RCT about DC in clinical settings without ICP monitors.

Public Health Relevance

The objective of this project is to build capacity in order to create a solid infrastructure for the implementation of Clinical Research in Neuro-trauma in Colombia. At the end of the study we will have preliminary data to support a RCT about decompressive Craniotomy applicable to most technologically deprived settings typical of most LMICs. This effort will allow generating high quality data on specific public health issues relevan to the actual environment and health needs in TBI in developing countries

Agency
National Institute of Health (NIH)
Institute
Fogarty International Center (FIC)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21TW009332-02
Application #
8436216
Study Section
Special Emphasis Panel (ZRG1-BDCN-Z (50))
Program Officer
Michels, Kathleen M
Project Start
2012-03-01
Project End
2014-02-28
Budget Start
2013-03-01
Budget End
2014-02-28
Support Year
2
Fiscal Year
2013
Total Cost
$88,368
Indirect Cost
$4,509
Name
University of Pittsburgh
Department
Surgery
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213