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CompletedNCT01461902PTBIUpdated Feb 2, 2015

Vasospasm in Pediatric Traumatic Brain Injury

An observational study in Brain Injury, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 5 Days to 15 Years. Per ClinicalTrials.gov, last updated 2015-02-02.

Sponsored by Duke University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Ages
5 Days to 15 Years
Sex
All
01

Study summary

The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.

02

Conditions studied

  • Brain Injury

Keywords

  • traumatic brain injury
  • brain injury
  • head injury
  • vasospasm
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 6 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Days to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.

Inclusion criteria

  1. admission to Duke University Children's Hospital;
  2. age 5 days to 15 years;
  3. a diagnosis of a TBI with a GCS 3-15;
  4. capable of adequate TCD ultrasound examination;
  5. and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.

Exclusion criteria

Exclusion Criteria:

  • the presence of previously diagnosed significant neurodevelopmental delay,
  • a diagnosis of non-traumatic intracranial hemorrhage and
  • parents/legal guardians who do not speak or understand English.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)

Groups and cohorts

  • Pediatric Traumatic Brain Injury

    Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury.

06

What researchers measure

Primary outcomes

  1. Vasospasm detection by Transcranial Doppler Ultrasound

    Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.

    Time frame: 8 days

Secondary outcomes

  1. Detection of biomarkers in pediatric traumatic brain injury

    Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.

    Time frame: 2 days

07

Study locations

1 site
  • Duke University medical Center
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01461902
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Oct 28, 2011
Start date
Sep 2011
Primary completion
Dec 2012
Completion
Dec 2013
Last update
Feb 2, 2015

Study contacts

Karin Reuter-Rice, PhD
principal investigator · Duke University School of Nursing and School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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