Vasospasm in Pediatric Traumatic Brain Injury (PTBI)
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ClinicalTrials.gov Identifier: NCT01461902 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : February 2, 2015
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Condition or disease |
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Brain Injury |
Study Type : | Observational |
Actual Enrollment : | 6 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2013 |

Group/Cohort |
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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.
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- Vasospasm detection by Transcranial Doppler Ultrasound [ Time Frame: 8 days ]Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.
- Detection of biomarkers in pediatric traumatic brain injury [ Time Frame: 2 days ]Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.

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Ages Eligible for Study: | up to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461902
United States, North Carolina | |
Duke University medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Karin Reuter-Rice, PhD | Duke University School of Nursing and School of Medicine |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01461902 |
Other Study ID Numbers: |
Pro00027860 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | February 2, 2015 |
Last Verified: | January 2015 |
traumatic brain injury brain injury head injury vasospasm |
Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |