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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00282269




Registration number
NCT00282269
Ethics application status
Date submitted
25/01/2006
Date registered
26/01/2006
Date last updated
22/06/2010

Titles & IDs
Public title
Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
Scientific title
Pilot Study of Early and Prolonged Hypothermia in Severe Traumatic Brain Injury in Children
Secondary ID [1] 0 0
NTX/06/02/002
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
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Induced Hypothermia

Treatment: Surgery: Induced Hypothermia
Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Paediatric Cerebral Performance Category (PCPC) at 12 months after injury
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Recruitment Rates
Timepoint [2] 0 0
Recruitment completion
Primary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
Recruitment completion
Secondary outcome [1] 0 0
Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control
Timepoint [1] 0 0
Recruitment completion
Secondary outcome [2] 0 0
Duration of mechanical ventilation
Timepoint [2] 0 0
Recruitment completion
Secondary outcome [3] 0 0
Intensive care and hospital length of stay
Timepoint [3] 0 0
Recruitment completion
Secondary outcome [4] 0 0
Neuropsychological Outcome
Timepoint [4] 0 0
12 months

Eligibility
Key inclusion criteria
* have a severe traumatic brain injury as defined by either a GCS = 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score = 3 and normal CT scan
* are aged between 1 and 16 years
* are mechanically ventilated
Minimum age
1 Year
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* are not randomized by 6 hours after injury
* have penetrating brain injuries
* have fixed dilated pupils and GCS = 3
* have proven cervical spinal cord injury
* have more than mild neurodevelopmental disability prior to injury
* have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal
* have had a post-traumatic seizure with a normal CT scan
* have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation

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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Alexandra Hospital for Children - Sydney
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [3] 0 0
Queensland Paediatric Intensive Care Services - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [6] 0 0
Princess Margaret Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Australia and New Zealand Intensive Care Society
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is:

* To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).
* To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).
Trial website
https://clinicaltrials.gov/study/NCT00282269
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Beca, FJFICM
Address 0 0
Starship Children's Hospital, Auckland, New Zealand
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/study/NCT00282269