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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059941
• Other study ID #: 44679
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: May 26, 2017
• Start date: September 30, 2012
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: Silvia Lujan, MD
• Phone: 549-341-560-9239
• Email: silviablujan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Bolivia	Hospital Viedma	Cochabamba
Bolivia	Hospital Japones	Santa Cruz de la Sierra
Bolivia	Hospital San Juan de Dios	Santa Cruz de la Sierra
Bolivia	Hospital San Juan de Dios	Tarija
Colombia	Fundacion Clinica Campbell	Barranquilla
Colombia	Clinica Universitaria Rafael Uribe	Cali
Colombia	Hospital Erasmo Meoz #1	Cucuta
Colombia	Hospital Erasmo Meoz #2	Cucuta
Ecuador	Hospital Jose Carrasco Arteaga	Cuenca
Ecuador	Hospital Espejo	Quito
Venezuela	Hospital Luis Razetti	Barcelona
Venezuela	Hospital Luis Razetti	Barinas
Venezuela	Hospital Dr. Patrocinio Penuela Ruiz	Cristobal

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Countries where clinical trial is conducted

Bolivia,  Colombia,  Ecuador,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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