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

May 26, 2017 updated by: Randall M. Chesnut, University of Washington

Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Not yet recruiting
        • Hospital Viedma
        • Contact:
          • Luis A Lavadenz, MD
          • Phone Number: 591-72709559
        • Contact:
      • Santa Cruz de la Sierra, Bolivia
        • Active, not recruiting
        • Hospital Japones
      • Santa Cruz de la Sierra, Bolivia
        • Not yet recruiting
        • Hospital San Juan de Dios
        • Contact:
          • Victor Alanis, MD
          • Phone Number: 591-70299888
        • Contact:
      • Tarija, Bolivia
        • Recruiting
        • Hospital San Juan de Dios
        • Contact:
          • Roberto M Merida, MD
          • Phone Number: 59170215050
        • Contact:
  • Colombia
      • Barranquilla, Colombia
        • Recruiting
        • Fundacion Clinica Campbell
        • Contact:
          • Ricardo Romero, MD
          • Phone Number: 573-1845392258
        • Contact:
      • Cali, Colombia
        • Recruiting
        • Clinica Universitaria Rafael Uribe
        • Contact:
        • Contact:
          • Oscar Pinillos, MD
          • Phone Number: 301-3765951
      • Cucuta, Colombia
        • Recruiting
        • Hospital Erasmo Meoz #1
        • Contact:
        • Contact:
          • Zulma Urbina, MD
          • Phone Number: 573-134414353
      • Cucuta, Colombia
        • Recruiting
        • Hospital Erasmo Meoz #2
        • Contact:
        • Contact:
          • Jairo Figeroa, MD
          • Phone Number: 573-3138534218
  • Ecuador
      • Cuenca, Ecuador
        • Recruiting
        • Hospital Jose Carrasco Arteaga
        • Contact:
        • Contact:
          • Soraya Puertas, MD
          • Phone Number: 593-99246924
      • Quito, Ecuador
        • Recruiting
        • Hospital Espejo
        • Contact:
        • Contact:
          • Manuel E Jibaja, MD
          • Phone Number: 593-99668588
  • Venezuela
      • Barcelona, Venezuela
        • Recruiting
        • Hospital Luis Razetti
        • Contact:
        • Contact:
          • Jacobo Mora, MD
          • Phone Number: 58-4142471196
      • Barinas, Venezuela
        • Recruiting
        • Hospital Luis Razetti
        • Contact:
        • Contact:
          • Rafael Davila
          • Phone Number: 58-41456703
      • Cristobal, Venezuela
        • Recruiting
        • Hospital Dr. Patrocinio Penuela Ruiz
        • Contact:
        • Contact:
          • Giannina B Martinez, MD
          • Phone Number: 58-4147119190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Galveston Orientation and Amnesia Test (GOAT
Time Frame: up to six months
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
Time Frame: up to six months
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
Time Frame: up to six months
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
Time Frame: up to six months
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)
Time Frame: up to six months
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)
Time Frame: up to six months
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)
Time Frame: up to six months
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
Time Frame: up to six months
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
Time Frame: up to six months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Randall M Chesnut, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2012

Primary Completion (Anticipated)

July 31, 2017

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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