Vasospasm in Pediatric Traumatic Brain Injury
Completed
- Conditions
- Brain Injury
- Registration Number
- NCT01461902
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- admission to Duke University Children's Hospital;
- age 5 days to 15 years;
- a diagnosis of a TBI with a GCS 3-15;
- capable of adequate TCD ultrasound examination;
- 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.
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vasospasm detection by Transcranial Doppler Ultrasound 8 days Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.
- Secondary Outcome Measures
Name Time Method Detection of biomarkers in pediatric traumatic brain injury 2 days Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.
Trial Locations
- Locations (1)
Duke University medical Center
🇺🇸Durham, North Carolina, United States