Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial pressure (ICP) monitors to assess ICH and know when and how to intervene. Unfortunately in most areas of the world there is no access to ICP monitor technology. This means that most people with sTBI are treated without use of ICP monitoring. There are no Guidelines and no literature on how to treat sTBI without use of ICP monitors. The objective of this project is to create guidelines for the treatment of severe TBI in the absence of ICP monitoring and test them. The grant is about to enter its 5th year and requires a 6th and 7th year in order to be completed successfully ? specifically, with sufficient power to rigorously test the guidelines. We have developed a treatment protocol by working with a team of clinicians who practice in resource-limited environ- ments in low-to-middle income countries (LMICs) and routinely make decisions based either on an ad hoc treatment protocol, their clinical experience, or both. During grant year 04 we held a consensus conference attended by clinicians from 14 Latin American countries and developed a Consensus-Based protocol that is now being tested in 15 resource-poor centers, some of which have prior exposure to a less well developed ad hoc protocol for treatment of TBI, and others that have not had prior exposure. We are testing the influence of the protocol on outcomes of severe TBI in a before/after design in these two sets of centers. In Phase I, (now complete), patients were treated according to an ad hoc protocol developed in a prior RCT (the BEST TRIP Trial) or according to individual clinician best judgment. Following development of the consensus protocol, all sites were trained in its use, and have begun implementing study Phase II which will last through year 07. In each set of centers we are evaluating the effect of using the consensus-based protocol compared to either no protocol or the ad hoc protocol by comparing the outcomes in the first and second periods (Phase I and Phase II). Finally, we will evaluate how much more the consensus-based protocol effects outcome than the ad hoc protocol by comparing the difference from the first to the second period between the two sets of sites. If this newly developed protocol is effective for treatment of severe TBI, it could be used globally to improve outcomes for sTBI patients in situations where ICP monitoring is not available as well as in high income centers that choose not to monitor. The innovative approach of doing such research in LMICs allows us to work ?from the ground up? in developing sTBI treatment algorithms and testing the marginal benefits of added technology or techniques. Although of clear value to the LMIC settings where the research is done, such studies also provide unique and valuable scientific feedback to High Income Country centers where many of these new technologies have been widely adopted in advance of rigorous scientific support for their efficacy.

Public Health Relevance

The objective of this project is to create guidelines for the treatment of severe TBI in the absence of ICP monitoring and test them using a before/after comparative effectiveness design. We have successfully completed the ?before? (Phase I) data collection part and have developed the new consensus-based protocol with Latin American experts from 14 countries. We are currently involved in the ?after? (Phase II) data collection part by testing the protocol in 15 Latin American centers.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
2R01NS080648-06
Application #
9309443
Study Section
Acute Neural Injury and Epilepsy Study Section (ANIE)
Program Officer
Bellgowan, Patrick S F
Project Start
2012-09-30
Project End
2019-07-31
Budget Start
2017-08-01
Budget End
2018-07-31
Support Year
6
Fiscal Year
2017
Total Cost
Indirect Cost
Name
University of Washington
Department
Neurosurgery
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya et al. (2018) A Method of Managing Severe Traumatic Brain Injury in the Absence of Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol. J Neurotrauma 35:54-63
Hendrickson, Peter; Pridgeon, James; Temkin, Nancy R et al. (2018) Development of a Severe Traumatic Brain Injury Consensus-Based Treatment Protocol Conference in Latin America. World Neurosurg 110:e952-e957
Iqbal, Zohaib; Verma, Gaurav; Kumar, Anand et al. (2017) Covariance J-resolved spectroscopy: Theory and application in vivo. NMR Biomed 30:
Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya et al. (2015) Ethical and methodological considerations on conducting clinical research in poor and low-income countries: Viewpoint of the authors of the BEST TRIP ICP randomized trial in Latin America. Surg Neurol Int 6:116
Rubiano, Andrés M; Carney, Nancy; Chesnut, Randall et al. (2015) Global neurotrauma research challenges and opportunities. Nature 527:S193-7
Chesnut, Randall M; Temkin, Nancy; Carney, Nancy et al. (2012) A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med 367:2471-81
Chesnut, Randall M; Temkin, Nancy; Carney, Nancy et al. (2012) Traumatic brain injury in Latin America: lifespan analysis randomized control trial protocol*. Neurosurgery 71:1055-63