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

Duke University1 site in 1 country6 target enrollmentSeptember 2011

ConditionsBrain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injury
Sponsor: Duke University
Enrollment: 6
Locations: 1
Primary Endpoint: Vasospasm detection by Transcranial Doppler Ultrasound
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

December 2013

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

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.