Vasospasm in Pediatric Traumatic Brain Injury

Brain Injury Clinical Trial

— PTBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461902
• Other study ID #: Pro00027860
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: January 30, 2015
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Locations

Country	Name	City	State
United States	Duke University medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasospasm detection by Transcranial Doppler Ultrasound	Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.	8 days	No
Secondary	Detection of biomarkers in pediatric traumatic brain injury	Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.	2 days	No