NCT01763892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

November 30, 2012

Last Update Submit

October 19, 2015

Conditions

Traumatic Brain Injury

Keywords

PediatricTraumatic Brain InjuryTBIApolipoprotein Eapo-EVasospasmGeneticsPhysiologic MechanismsNeurocognitive OutcomesEndothelin 1

Outcome Measures

Primary Outcomes (1)

  • Presence of apolipoprotein E (apo-E) allele

    Collection of Apo-E allele will be obtained by buccal swab upon enrollment

    Day 1

Secondary Outcomes (1)

  • Vasospasm detection by Transcranial Doppler Ultrasound (TCD)

    8 days

Other Outcomes (1)

  • Biomarker Detection

    5 days

Study Arms (1)

Children admitted to hospital with a TBI

non-intervention study

Eligibility Criteria

Age5 Days - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Apolipoprotein E (apo-E) genotype/SNPs Endothelin 1 genotype/SNPs

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Karin Reuter-Rice, PhD

    DUSON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

January 9, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

US(1)