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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
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
White matter fractional anisotropy
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Brain network connectivity
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
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institutes of Health (NIH)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [2] 0 0
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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