Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:

Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763892
• Other study ID #: Pro00040284
• Secondary ID: 712441P30NR01413
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: October 19, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker Detection	Detection of a defined set of protein biomarkers from biological samples collected at baseline, 24, 48, and 96 hours.	5 days	No
Primary	Presence of apolipoprotein E (apo-E) allele	Collection of Apo-E allele will be obtained by buccal swab upon enrollment	Day 1	No
Secondary	Vasospasm detection by Transcranial Doppler Ultrasound (TCD)	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.	8 days	No