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Completed

NCT Number: NCT01461902

Vasospasm in Pediatric Traumatic Brain Injury

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

5 day–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Vasospasm detection by Transcranial Doppler Ultrasound

    Time frame: 8 days

    Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury

Acronym: PTBI

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 28, 2011
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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