Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

This study has been completed.
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University Identifier:
First received: November 30, 2012
Last updated: October 19, 2015
Last verified: October 2015
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.

Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Presence of apolipoprotein E (apo-E) allele [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Collection of Apo-E allele will be obtained by buccal swab upon enrollment

Secondary Outcome Measures:
  • Vasospasm detection by Transcranial Doppler Ultrasound (TCD) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    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:
  • Biomarker Detection [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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

Enrollment: 60
Study Start Date: December 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Children admitted to hospital with a TBI
non-intervention study

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.

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT01763892

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)
Principal Investigator: Karin Reuter-Rice, PhD DUSON
  More Information

No publications provided

Responsible Party: Duke University Identifier: NCT01763892     History of Changes
Other Study ID Numbers: Pro00040284, 71244, 1P30NR014139-01
Study First Received: November 30, 2012
Last Updated: October 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Traumatic Brain Injury
Apolipoprotein E
Physiologic Mechanisms
Neurocognitive Outcomes
Endothelin 1

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on November 27, 2015