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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04077411




Registration number
NCT04077411
Ethics application status
Date submitted
29/08/2019
Date registered
4/09/2019

Titles & IDs
Public title
Approaches and Decisions for Acute Pediatric TBI Trial
Scientific title
Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
Secondary ID [1] 0 0
U01NS081041
Secondary ID [2] 0 0
PRO13020047
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Traumatic Brain Injury 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
Other interventions - Observational

Children with severe TBI - Children with severe Traumatic Brain Injury


Other interventions: Observational
This is an observational study with no interventions.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glasgow Outcome Score - Extended Pediatrics
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Admission to a study site for treatment of severe traumatic brain injury
* ICP monitor placed as part of the child's standard care
* Glasgow Coma Scale (GCS) = 8 after resuscitation
* Age 0 - 18 y
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1. ICP Monitor placed at another hospital
* 2. Diagnosis of pregnancy in clinical subject

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2018
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Children's Health Queensland Hospital and Health Service - Brisbane
Recruitment hospital [2] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [3] 0 0
Princess Margaret Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Iowa
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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North Carolina
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Pennsylvania
Country [17] 0 0
United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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India
State/province [23] 0 0
New Delhi
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Netherlands
State/province [24] 0 0
Rotterdam
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New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
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Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Birmingham
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Bristol
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United Kingdom
State/province [30] 0 0
Cambridge
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United Kingdom
State/province [31] 0 0
Leeds
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Liverpool
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United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Newcastle upon Tyne
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Southampton
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Victoria

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pittsburgh
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michael J Bell, MD
Address 0 0
University of Pittsburgh Medical Center
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?
Study data will be released to the general public through FITBIR. ADAPT will adhere to all FITBIR policies and procedures.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
One year after publication of main results paper.
Available to whom?
Investigators requesting and receiving FITBIR data are expected to:

* Submit a Data Access Request;
* Protect data confidentiality;
* Ensure that data security measures are in place;
* Notify the Data Access and Quality Committee of policy violations;
* Submit annual progress reports detailing significant research findings; and
* Include acknowledgements of the FITBIR Informatics System in all publications and presentations.
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/NCT04077411