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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01461902 |
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Date of registration:
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26/10/2011 |
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Primary sponsor: |
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Public title:
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Vasospasm in Pediatric Traumatic Brain Injury
PTBI |
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Scientific title:
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Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01461902 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Karin Reuter-Rice, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University School of Nursing and School of Medicine |
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Key inclusion & exclusion criteria
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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:
- 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.
Age minimum:
N/A
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain Injury
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Primary Outcome(s)
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Vasospasm detection by Transcranial Doppler Ultrasound
[Time Frame: 8 days]
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Secondary Outcome(s)
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Detection of biomarkers in pediatric traumatic brain injury
[Time Frame: 2 days]
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Secondary ID(s)
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Pro00027860
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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