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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02688660




Registration number
NCT02688660
Ethics application status
Date submitted
29/01/2016
Date registered
23/02/2016

Titles & IDs
Public title
MRI Markers of Outcome After Severe Pediatric TBI
Scientific title
MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)
Secondary ID [1] 0 0
R01NS092870
Secondary ID [2] 0 0
2015-0185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injuries 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ADAPT Study Population - This cohort will be subjects from the ADAPT study who had an acute MRI scan which has been uploaded into the ADAPT database from all participating sites.

Follow-Up MRI - This cohort will include patients from ADAPT sites who choose to participate in this option and obtain a follow-up MRI approximately 1 year after the TBI.

Healthy Controls - This cohort will have one MRI to be used in comparison of the above cohorts.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cerebral Atrophy
Assessment method [1] 0 0
Global and regional cerebral atrophy will be assessed using MRI
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
White matter fractional anisotropy
Assessment method [2] 0 0
Fractional Anisotropy will be assessed using Diffusion Tensor MRI
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Brain network connectivity
Assessment method [3] 0 0
Network connectivity will be assessed using resting-state functional MRI
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
Aim 1 Subjects:

* Children 0 through < 18 years of age
* Diagnosis of severe TBI (defined as a Glasgow Coma Scale (GCS) score less than or equal to 8)
* Had an intracranial pressure (ICP) monitor as part of standard care

Aims 2 & 3 Subjects:

* Children 9 through < 18 years of age with severe TBI
* Consent for a follow-up MRI within 10 years of the time of TBI

Controls:

* Healthy children greater than or equal to 9 and < 18 years of age.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* TBI & controls:
* Anyone unable to tolerate a non-sedated MRI

Controls:

* Any history of head injury resulting in loss of consciousness
* Standard contraindications to MRI (metallic implants, implanted electronic devices, pregnancy, etc.).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2022
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
United Kingdom
State/province [16] 0 0
England
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Hampshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institutes of Health (NIH)
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Ferrazzano, MD
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02688660