NCT01461902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

October 26, 2011

Last Update Submit

January 30, 2015

Conditions

Brain Injury

Keywords

traumatic brain injurybrain injuryhead injuryvasospasm

Outcome Measures

Primary Outcomes (1)

  • Vasospasm detection by Transcranial Doppler Ultrasound

    Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.

    8 days

Secondary Outcomes (1)

  • Detection of biomarkers in pediatric traumatic brain injury

    2 days

Study Arms (1)

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.

Eligibility Criteria

Age5 Days - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Karin Reuter-Rice, PhD

    Duke University School of Nursing and School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

US(1)