Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines

NCT02059941 | Unknown

• 1 other identifier: 44679
• Study Type: observational
• Target: 780
• Locations: 4 countries
• Sites: 13

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.

Conditions

Traumatic Brain Injury

Keywords

Severe traumatic brain injury, ICP, Latin America, outcomes

Outcome Measures

Primary Outcomes (9)

• The Galveston Orientation and Amnesia Test (GOAT

  brief questionnaire that assesses orientation to time, place and person as well as post traumatic and retrograde amnesia. For this study, only the mental status portions of the measure will be used.

  up to six months

• Color Trails Test

  used to examine sustained and divided attention as well as mental flexibility. This is a two-part paper-pencil test measuring visual tracking. Part 1 requires the subject to connect 25 circles numbered 1 through 25, in sequence, distributed over a white sheet of paper, as quickly as possible. Part 2 is more complex and requires the person to connect the 25 numbered circles but alternating between pink and yellow colors. The scores obtained are the number of seconds required to complete each part of the test.

  up to six months

• Spanish verbal learning test

  consists of 16 words that the subject needs to learn over 5 trials with recall after each presentation. The score consists of the sum of correct recall over 5 trials. Delayed recall trial obtained 30 minutes later

  up to six months

• Symbol Search subtest of the Wechsler Adult Intelligence

  a measure of information processing speed. On this task the subject is presented with a pair of target symbols and must scan a search group of symbols to determine if there is a match.

  up to six months

• The Glasgow Outcome Scale - Extended (GOSE)

  score is obtained by a structured interview format that identifies specific criteria for assigning an outcome category. Outcome categories range from 1 (Dead) to 8 (Upper good recovery).

  up to six months

• Functional Status Examination (FSE)

  Outcome is examined in personal care, ambulation, mobility, major activities (i.e. work, school), home management, leisure and recreation, social integration, cognitive/behavioral competency and standard of living. These areas are evaluated using the concept of dependency to operationally define outcome at four levels. The first level signifies no change, the second level signifies difficulty in performing the activity although the person is still independent, the third level signifies dependence on others some of the time, and the fourth level signifies nonperformance or inability to perform the activity or total dependence on others.

  up to six months

• Satisfaction with Life Scale (SWL)

  a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. The scale usually requires only about one minute of a respondent's time.

  up to six months

• The Euroqol

  is a standardized instrument to measure health outcome on 5 dimensions; Mobility, Self-Care, Usual Activities, Pain and Depression/Anxiety. It typically takes only a few minutes to complete.

  up to six months

• Structured interview

  is a questionnaire that obtains pre-injury demographic information (e.g., age, gender, nationality, race, ethnicity, education, medical history etc.) and pre- and post-injury information on marital status, employment history, living situation, and drug and alcohol use.

  up to six months

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (13)

Hospital Viedma

Cochabamba, Bolivia

NOT YET RECRUITING

Hospital Japones

Santa Cruz de la Sierra, Bolivia

ACTIVE NOT RECRUITING

Hospital San Juan de Dios

Santa Cruz de la Sierra, Bolivia

NOT YET RECRUITING

Hospital San Juan de Dios

Tarija, Bolivia

RECRUITING

Fundacion Clinica Campbell

Barranquilla, Colombia

RECRUITING

Clinica Universitaria Rafael Uribe

Cali, Colombia

RECRUITING

Hospital Erasmo Meoz #1

Cúcuta, Colombia

RECRUITING

Hospital Erasmo Meoz #2

Cúcuta, Colombia

RECRUITING

Hospital Jose Carrasco Arteaga

Cuenca, Ecuador

RECRUITING

Hospital Espejo

Quito, Ecuador

RECRUITING

Hospital Luis Razetti

Barcelona, Venezuela

RECRUITING

Hospital Luis Razetti

Barinas, Venezuela

RECRUITING

Hospital Dr. Patrocinio Penuela Ruiz

Cristobal, Venezuela

RECRUITING

Related Publications (1)

• 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.

  PMID: 30265194 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Randall M Chesnut, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Lujan, MD

CONTACT

549-341-560-9239; silviablujan@gmail.com

Gustavo Petroni, MD

CONTACT

549-341-485-5074; gustavopetroni@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurological Surgery

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: September 30, 2012
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2019
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CO (4); BO (4); EC (2); VE (3)