Status:
COMPLETED
Vasospasm in Pediatric Traumatic Brain Injury
Lead Sponsor:
Duke University
Conditions:
Brain Injury
Eligibility:
All Genders
5-15 years
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) pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01461902
Start Date
September 1 2011
End Date
December 1 2013
Last Update
February 2 2015
Active Locations (1)
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1
Duke University medical Center
Durham, North Carolina, United States, 27710