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Vasospasm in Pediatric Traumatic Brain Injury (PTBI)

This study has been completed.
Information provided by (Responsible Party):
Duke University Identifier:
First received: October 26, 2011
Last updated: January 30, 2015
Last verified: January 2015
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.

Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Duke University:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 6
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.


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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01461902

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

Responsible Party: Duke University Identifier: NCT01461902     History of Changes
Other Study ID Numbers: Pro00027860
Study First Received: October 26, 2011
Last Updated: January 30, 2015

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on August 18, 2017