Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)|
- 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
- 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.
- 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
|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)|
Children admitted to hospital with a traumatic brain injury
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763892
|Contact: Karin Reuter-Rice, PhDfirstname.lastname@example.org|
|Contact: Nancy Hassellemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Karin Reuter-Rice, PhD|