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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Vasospasm detection by Transcranial Doppler Ultrasound [ Time Frame: 8 days ]
    Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.


Secondary Outcome Measures :
  1. 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
Study Population
Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Duke University medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Karin Reuter-Rice, PhD Duke University School of Nursing and School of Medicine

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01461902     History of Changes
Other Study ID Numbers: Pro00027860
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by Duke University:
traumatic brain injury
brain injury
head injury
vasospasm

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System