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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Randall M. Chesnut, University of Washington
Sponsor:
Information provided by (Responsible Party):
Randall M. Chesnut, University of Washington
ClinicalTrials.gov Identifier:
NCT02059941
First received: February 7, 2014
Last updated: May 26, 2017
Last verified: May 2017
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing

Resource links provided by NLM:


Further study details as provided by Randall M. Chesnut, University of Washington:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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

  • 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.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 780
Actual Study Start Date: September 30, 2012
Estimated Study Completion Date: July 31, 2019
Estimated Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059941

Contacts
Contact: Silvia Lujan, MD 549-341-560-9239 silviablujan@gmail.com
Contact: Gustavo Petroni, MD 549-341-485-5074 gustavopetroni@gmail.com

Locations
Bolivia
Hospital Viedma Not yet recruiting
Cochabamba, Bolivia
Contact: Luis A Lavadenz, MD    591-72709559      
Contact: Siliva Lujan, MD    549-3414855074    silviablujan@gmail.com   
Hospital Japones Active, not recruiting
Santa Cruz de la Sierra, Bolivia
Hospital San Juan de Dios Not yet recruiting
Santa Cruz de la Sierra, Bolivia
Contact: Victor Alanis, MD    591-70299888      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital San Juan de Dios Recruiting
Tarija, Bolivia
Contact: Roberto M Merida, MD    59170215050      
Contact: Siliva Lujan, MD    549-3415609329    silviablujan@gmail.com   
Colombia
Fundacion Clinica Campbell Recruiting
Barranquilla, Colombia
Contact: Ricardo Romero, MD    573-1845392258      
Contact: Silvia Lujan, MD    549-3415609230    silviablujan@gmail.com   
Clinica Universitaria Rafael Uribe Recruiting
Cali, Colombia
Contact: Oscar Pinillos, MD    301-3765951      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Erasmo Meoz #1 Recruiting
Cucuta, Colombia
Contact: Zulma Urbina, MD    573-134414353      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Erasmo Meoz #2 Recruiting
Cucuta, Colombia
Contact: Jairo Figeroa, MD    573-3138534218      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Ecuador
Hospital Jose Carrasco Arteaga Recruiting
Cuenca, Ecuador
Contact: Soraya Puertas, MD    593-99246924      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Espejo Recruiting
Quito, Ecuador
Contact: Manuel E Jibaja, MD    593-99668588      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Venezuela
Hospital Luis Razetti Recruiting
Barcelona, Venezuela
Contact: Jacobo Mora, MD    58-4142471196      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Luis Razetti Recruiting
Barinas, Venezuela
Contact: Rafael Davila    58-41456703      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Dr. Patrocinio Penuela Ruiz Recruiting
Cristobal, Venezuela
Contact: Giannina B Martinez, MD    58-4147119190      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Randall M Chesnut, MD University of Washington
  More Information

Responsible Party: Randall M. Chesnut, Professor, Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT02059941     History of Changes
Other Study ID Numbers: 44679
Study First Received: February 7, 2014
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Randall M. Chesnut, University of Washington:
Severe traumatic brain injury, ICP, Latin America, outcomes

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on June 22, 2017