Traumatic Brain InjuryNCT02059941
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
An observational study of Traumatic Brain Injury, run by University of Washington at 13 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 780 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 30 Sep 2012to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Bolivia4 sites, 3 recruiting
- Not yet recruiting
Hospital Viedma
Cochabamba
Luis A Lavadenz, MD, 591-72709559
Siliva Lujan, MD, 549-3414855074, silviablujan@gmail.com
- Active, not recruiting
Hospital Japones
Santa Cruz de la Sierra
- Not yet recruiting
Hospital San Juan de Dios
Santa Cruz de la Sierra
Victor Alanis, MD, 591-70299888
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital San Juan de Dios
Tarija
Roberto M Merida, MD, 59170215050
Siliva Lujan, MD, 549-3415609329, silviablujan@gmail.com
Colombia4 sites, 4 recruiting
- Recruiting
Fundacion Clinica Campbell
Barranquilla
Ricardo Romero, MD, 573-1845392258
Silvia Lujan, MD, 549-3415609230, silviablujan@gmail.com
- Recruiting
Clinica Universitaria Rafael Uribe
Cali
Oscar Pinillos, MD, 301-3765951
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital Erasmo Meoz #1
Cúcuta
Zulma Urbina, MD, 573-134414353
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital Erasmo Meoz #2
Cúcuta
Jairo Figeroa, MD, 573-3138534218
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
Venezuela3 sites, 3 recruiting
- Recruiting
Hospital Luis Razetti
Barcelona
Jacobo Mora, MD, 58-4142471196
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital Luis Razetti
Barinas
Rafael Davila, 58-41456703
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital Dr. Patrocinio Penuela Ruiz
Cristobal
Giannina B Martinez, MD, 58-4147119190
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
Ecuador2 sites, 2 recruiting
- Recruiting
Hospital Jose Carrasco Arteaga
Cuenca
Soraya Puertas, MD, 593-99246924
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
- Recruiting
Hospital Espejo
Quito
Manuel E Jibaja, MD, 593-99668588
Silvia Lujan, MD, 549-3415609239, silviablujan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Severe traumatic brain injury, ICP, Latin America, outcomes
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start30 Sep 2012
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall M. Chesnut, University of Washington
- Investigators
- Randall M Chesnut, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059941
- Sponsor's protocol ID
- 44679
- Status last verified
- May 2017
- First submitted
- 7 Feb 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30265194
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing
- ClinicalTrials.gov ID
- NCT02059941
- Acronym / sponsor ID
- 44679
- Conditions
- Traumatic Brain Injury
- Keywords
- Severe traumatic brain injury, ICP, Latin America, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 30 Sep 2012 (actual)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 30265194Alali 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall M Chesnut, MD principal investigator
University of Washington
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Washington at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Bolivia, Colombia, Venezuela, Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Lujan, MD (549-341-560-9239, silviablujan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Galveston Orientation and Amnesia Test (GOAT (time frame: up to six months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.