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Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01763892
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : October 20, 2015
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the apo-E genotype will help us know if injury response is altered in certain children and will aid in developing interventional approaches.

Condition or disease
Traumatic Brain Injury

Detailed Description:
The purpose of this study is to advance knowledge of neurocognitive outcomes in pediatric traumatic brain injury (TBI) patients by exploring the relationships between physiologic factors of cerebral vasospasm, apolipoprotein E (apo-E) allele, biomarkers, and neurocognitive outcomes. This study is a funded project within Duke University School of Nursing National Institutes of Health/National Institute of Nursing Research (NIH/NINR) P30 Center of Excellence Grant. This study will continue on with some of the work of a small intramural grant study determining the feasibility of conducting pediatric TBI research at DUHS. It will advance the measurement of vasospasm by translating the use of the Transcranial Doppler (TCD) ultrasound to neuromonitoring in children. To date, this will be the first pediatric study examining the relationship of cerebral vasospasm, apo-E, and biomarkers with neurocognitive outcomes. Unlike adult TBI patients, cerebral vasospasm, apo-E, and biomarker collections have yet to be examined in pediatric neurotrauma patients in the Duke University Health System. Although neurocognitive outcomes are a standard of care for TBI patients at Duke University Health System (DUHS), the data has yet to be examined within the realm of pediatric neurodiagnostic physiologic measures. By obtaining preliminary data in 35 patients, it will allow for the evaluation of multi-diagnostic measures in pediatric TBI patients, as well as provide data for future funding for a larger regionally-scale study.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)
Study Start Date : December 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Children admitted to hospital with a TBI
non-intervention study

Primary Outcome Measures :
  1. Presence of apolipoprotein E (apo-E) allele [ Time Frame: Day 1 ]
    Collection of Apo-E allele will be obtained by buccal swab upon enrollment

Secondary Outcome Measures :
  1. Vasospasm detection by Transcranial Doppler Ultrasound (TCD) [ Time Frame: 8 days ]
    Daily Transcranial doppler ultrasound will performed in pediatric traumatic brain injury patients through hospital day 8. If vasospasm is present and persists beyond hospital day 8, daily TCD examinations will be continued until resolution of vasospasm is noted.

Other Outcome Measures:
  1. Biomarker Detection [ Time Frame: 5 days ]
    Detection of a defined set of protein biomarkers from biological samples collected at baseline, 24, 48, and 96 hours.

Biospecimen Retention:   Samples With DNA
Apolipoprotein E (apo-E) genotype/SNPs Endothelin 1 genotype/SNPs

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  1. TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit
  2. Range in age from birth to 15 years
  3. TBI with a Glasgow Coma Scale of 3-15
  4. Acoustic window for adequate transcranial doppler (TCD) ultrasound
  5. English or Spanish speaking or understanding parent/legal guardian to consent
  6. Access for a buccal swab for genotyping

Exclusion Criteria:

  1. Non-English or Spanish speaking parents/legal guardian
  2. Children with a previously diagnosed neurodevelopmental delay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01763892

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Nursing Research (NINR)
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Principal Investigator: Karin Reuter-Rice, PhD DUSON

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Responsible Party: Duke University Identifier: NCT01763892     History of Changes
Other Study ID Numbers: Pro00040284
71244 ( Other Grant/Funding Number: RWJF )
1P30NR014139-01 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Duke University:
Traumatic Brain Injury
Apolipoprotein E
Physiologic Mechanisms
Neurocognitive Outcomes
Endothelin 1
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System