Clinical trial NCT02059941: Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
Official title: Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: Severe traumatic brain injury, ICP, Latin America, outcomes
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 780
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, there will be about 780 study subjects from 14 sites in Latin America. Subjects will be about 390 from clinical sites previously exposed to protocols for management of TBI, and about 390 from sites without prior exposure to protocols. Half of the study subjects (about 390 total) will be treated in accordance with a consensus-based protocol. Subjects will consist of patients with TBIs sufficiently severe to fulfill the inclusion criteria. To qualify, patients must be 13 or older and have a non-penetrating traumatic brain injury. The major criterion is severe TBI to be treated without the use of intracranial pressure monitoring

Brief summary: 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 guide intervention. Unfortunately, only a small percentage of the world has the resources and capability to routinely monitor ICP.

The objective of this proposal is to create and test guidelines for the treatment of severe TBI in the absence of ICP monitoring.

Detailed description: Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury (TBI) 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 severe TBI are treated without use of ICP monitoring. There are no Guidelines and no literature on how to treat severe TBI 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. We propose to derive these guidelines by working with a team of clinicians that practice in austere environments in low-to-middle income countries (LMICs) and routinely make decisions based either on a treatment protocol, their clinical experience, or both. We will use a new, systematic and innovative technology and process to accomplish consensus for the guidelines among the clinicians. We will implement the Consensus-Based Guidelines (CBG) in resource-poor centers, some of which have prior exposure to less well developed ad hoc protocols for treatment of TBI, and others that do not have prior exposure. We will test the influence of the CBG on outcomes of severe TBI in a before/after design in these two sets of centers. In the first two years, patients will be treated according to the ad hoc protocol or according to individual clinician best judgment. Then the Guidelines will be developed, all sites will be trained in their use, and they will be used to guide treatment in all sites for the next 2 years. .We will evaluate the effect of using an ad hoc protocol by comparing outcomes between the two sets of centers before the Guidelines are developed. In each set of centers we will evaluate the effect of using the consensus-based guideline protocol compared to either no protocol or the ad hoc protocol by comparing the outcomes in the first and second periods. 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

In accomplishing the study objectives, we will create and test a guideline for the treatment of severe TBI that could be used globally to improve outcomes for these patients. We will validate in LMICs a new, systematic and innovative technology and process to accomplish consensus that was derived in an HIC. Finally, we will train personnel in centers new to research in how to conduct high-quality scientific studies, and will extend the training for the personnel with whom we have been working, solidifying previous capacity-building efforts, and initiating new efforts.

Eligibility criteria: Inclusion Criteria:

* Non-penetrating TBI
* Post-resuscitation Glasgow Coma Scale score (GCS) ≤ 8, and GCS Motor score ≤ 5, or Deterioration to those values within 48 hours of injury
* Age 13 years or older
* Consent to participate signed by Legally Authorized Representative (LAR)

Exclusion Criteria:

* GCS of 3 with bilateral fixed and dilated pupils and/or decision to not actively treat prior to enrolment into study
* Prisoner
* No consent
* Non-survivable injury
* Other (e.g., Pre-injury life expectancy under 1 year)
* Pre-existing neurological disability that would not allow follow-up

Primary outcomes:
measure: The Galveston Orientation and Amnesia Test (GOAT
timeFrame: up to six months
measure: Color Trails Test
timeFrame: up to six months
measure: Spanish verbal learning test
timeFrame: up to six months
measure: Symbol Search subtest of the Wechsler Adult Intelligence
timeFrame: up to six months
measure: The Glasgow Outcome Scale - Extended (GOSE)
timeFrame: up to six months
measure: Functional Status Examination (FSE)
timeFrame: up to six months
measure: Satisfaction with Life Scale (SWL)
timeFrame: up to six months
measure: The Euroqol
timeFrame: up to six months
measure: Structured interview
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Hospital Viedma
city: Santa Cruz de la Sierra
country: Bolivia
facility: Hospital Japones
city: Santa Cruz de la Sierra
country: Bolivia
facility: Hospital San Juan de Dios
city: Tarija
country: Bolivia
facility: Hospital San Juan de Dios
city: Barranquilla
country: Colombia
facility: Fundacion Clinica Campbell
city: Cali
country: Colombia
facility: Clinica Universitaria Rafael Uribe
city: Cucuta
country: Colombia
facility: Hospital Erasmo Meoz #1
city: Cucuta
country: Colombia
facility: Hospital Erasmo Meoz #2
city: Cuenca
country: Ecuador
facility: Hospital Jose Carrasco Arteaga
city: Quito
country: Ecuador
facility: Hospital Espejo
city: Barcelona
country: Venezuela
facility: Hospital Luis Razetti
city: Barinas
country: Venezuela
facility: Hospital Luis Razetti
city: Cristobal
country: Venezuela
facility: Hospital Dr. Patrocinio Penuela Ruiz
Study officials:
affiliation: University of Washington
name: Randall M Chesnut, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alali AS, Temkin N, Barber J, Pridgeon J, Chaddock K, Dikmen S, Hendrickson P, Videtta W, Lujan S, Petroni G, Guadagnoli N, Urbina Z, Chesnut RM. A clinical decision rule to predict intracranial hypertension in severe traumatic brain injury. J Neurosurg. 2018 Sep 28;131(2):612-619. doi: 10.3171/2018.4.JNS173166. Print 2019 Aug 1.