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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00222742




Registration number
NCT00222742
Ethics application status
Date submitted
16/09/2005
Date registered
22/09/2005
Date last updated
11/07/2012

Titles & IDs
Public title
Hypothermia in Children After Trauma
Scientific title
Pediatric Traumatic Brain Injury Consortium: Hypothermia
Secondary ID [1] 0 0
1R01NS052478-01
Secondary ID [2] 0 0
1R01-NS052478-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - induced moderate hypothermia

Experimental: A - Induced moderate hypothermia (32-33 C)


Treatment: Surgery: induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary specific aim of this RCT is to determine the effect of induced moderate HYPO (32-33 °C) after severe TBI in children on mortality.
Timepoint [1] 0 0
3 month post injury
Secondary outcome [1] 0 0
To determine the effect of HYPO after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability/development, memory and learning, and behavior.
Timepoint [1] 0 0
at 6 and 12 months post injury
Secondary outcome [2] 0 0
To determine the effect of HYPO after severe TBI in children of different age ranges (< 6y; 6-<16y; and 16-<18y) on mortality and 6 and 12 months functional and neurocognitive outcomes.
Timepoint [2] 0 0
3, 6 and 12 months post injury
Secondary outcome [3] 0 0
To determine the effect of HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP).
Timepoint [3] 0 0
7 days post injury

Eligibility
Key inclusion criteria
1. Patients with a GCS </= 8

2. Glasgow Motor Score < 6

3. Closed head injury

4. Age 0 < 18 y
Minimum age
No limit
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Unavailable to initiate cooling within 6 hours of injury

2. Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function

3. Normal initial CT scan (No blood, fracture, swelling, and/or shift)

4. Penetrating brain injury

5. No known mechanism of injury

6. Unknown time of injury

7. Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7)

8. Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min)

9. Documented Hypoxic episode (O2 saturation < 94% for > 30 min)

10. Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital, Randwick - Sydney
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital, Brisbane - Brisbane
Recruitment hospital [4] 0 0
Mater Children's Hospital - Brisbane
Recruitment hospital [5] 0 0
Children's Youth and Women's Health Service - North Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Subiaco, Perth
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6008 - Subiaco, Perth
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
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
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
South Africa
State/province [16] 0 0
Cape Town
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Other
Name
Phoenix Children's Hospital
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

Ethics approval
Ethics application status

Summary
Brief summary
The primary hypothesis for this application for a multicenter phase III randomized clinical
trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic
brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months
and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).
Trial website
https://clinicaltrials.gov/show/NCT00222742
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
P. David Adelson, MD
Address 0 0
Phoenix Children's Hospital
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00222742