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Vasospasm in Pediatric Traumatic Brain Injury (PTBI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01461902
First received: October 26, 2011
Last updated: January 27, 2014
Last verified: December 2012
  Purpose

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
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01461902     History of Changes
Other Study ID Numbers: Pro00027860
Study First Received: October 26, 2011
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014