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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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
India
State/province [23] 0 0
New Delhi
Country [24] 0 0
Netherlands
State/province [24] 0 0
Rotterdam
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
Country [27] 0 0
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
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cambridge
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Leeds
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Liverpool
Country [33] 0 0
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


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