Vasospasm in Pediatric Traumatic Brain Injury

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01461902

Acronym

PTBI

Enrollment

Registered

2011-10-28

Start date

2011-09-30

Completion date

2013-12-31

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury

Keywords

traumatic brain injury, brain injury, head injury, vasospasm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Days to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Vasospasm detection by Transcranial Doppler Ultrasound	8 days	Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.

Secondary

Measure	Time frame	Description
Detection of biomarkers in pediatric traumatic brain injury	2 days	Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.

Countries

United States

Outcome results