Vasospasm in Pediatric Traumatic Brain Injury (PTBI)

Duke University

Status: Completed

Conditions: Brain Injury

Study type: Observational

Funder types: Other

Identifiers

NCT01461902

Pro00027860

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 5 days to 15 years old

Volunteers: No 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.

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.

Trial design

6 participants in 1 patient group

Pediatric Traumatic Brain Injury

Description:

Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury.