Vasospasm in Pediatric Traumatic Brain Injury | NCT01461902

Studies
Vasospasm in Pediatric Traumatic Brain Injury

NCT01461902

Sponsor

Duke University

Status

Completed

Last Update Posted

Feb 2, 2015Estimated

Enrollment

6Actual

Phase

Not provided

Conditions

Brain Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 26, 2011

First Submission Date that Met QC Criteria

Oct 27, 2011

First Posted Date

Oct 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Days

Maximum Age

15 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karin Reuter-Rice, PhD	Duke University School of Nursing and School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University medical Center		Durham	North Carolina	27710	United States

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries
D000070642	Brain Injuries, Traumatic
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided