Vasospasm in Pediatric Traumatic Brain Injury

NCT ID: NCT01461902

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Traumatic Brain Injury

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

No interventions assigned to this group

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Reuter-Rice, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing and School of Medicine

Locations

Duke University medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00027860

Identifier Type: -

Identifier Source: org_study_id