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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02059941 |
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Date of registration:
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07/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
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Scientific title:
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Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing |
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Date of first enrolment:
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September 30, 2012 |
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Target sample size:
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780 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02059941 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Bolivia
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Colombia
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Ecuador
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Venezuela
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Contacts
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Name:
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Silvia Lujan, MD |
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Address:
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Telephone:
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549-341-560-9239 |
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Email:
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silviablujan@gmail.com |
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Affiliation:
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Name:
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Randall M Chesnut, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Traumatic Brain Injury
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Primary Outcome(s)
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Color Trails Test
[Time Frame: up to six months]
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Functional Status Examination (FSE)
[Time Frame: up to six months]
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Satisfaction with Life Scale (SWL)
[Time Frame: up to six months]
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The Euroqol
[Time Frame: up to six months]
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Spanish verbal learning test
[Time Frame: up to six months]
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The Glasgow Outcome Scale - Extended (GOSE)
[Time Frame: up to six months]
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Symbol Search subtest of the Wechsler Adult Intelligence
[Time Frame: up to six months]
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Structured interview
[Time Frame: up to six months]
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The Galveston Orientation and Amnesia Test (GOAT
[Time Frame: up to six months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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