Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01763892
First received: November 30, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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
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


Estimated Enrollment: 35
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children admitted to hospital with a traumatic brain injury
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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children

Criteria

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 speaking or understanding parent/legal guardian to consent
  6. Access for a buccal swab for genotyping

Exclusion Criteria:

  1. Non-English 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 ClinicalTrials.gov identifier: NCT01763892

Contacts
Contact: Karin Reuter-Rice, PhD 919-681-7647 karin.reuter-rice@duke.edu
Contact: Nancy Hassell nancy.hassell@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Karin Reuter-Rice, PhD         
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01763892     History of Changes
Other Study ID Numbers: Pro00040284
Study First Received: November 30, 2012
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Pediatric
Traumatic Brain Injury
TBI
Apolipoprotein E
apo-E
Vasospasm
Genetics
Physiologic Mechanisms
Neurocognitive Outcomes

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014