Traumatic Brain InjuryPhase 2/3NCT00282269
Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
A Phase 2/3 study testing Induced Hypothermia in people with Traumatic Brain Injury, run by Australia and New Zealand Intensive Care Society at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Induced Hypothermia
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2006to Jun 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Women's and Children's Hospital
Adelaide, South Australia
Queensland Paediatric Intensive Care Services
Brisbane, Queensland
Royal Children's Hospital
Melbourne, Victoria
Princess Margaret Hospital
Perth, Western Australia
Royal Alexandra Hospital for Children
Sydney, New South Wales
Sydney Children's Hospital
Sydney, New South Wales
About this study
Official title: Pilot Study of Early and Prolonged Hypothermia in Severe Traumatic Brain Injury in Children
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).
Read the detailed description
We propose to do a pilot study of 50 children admitted with severe TBI to paediatric intensive care units in Australia and New Zealand. Severe TBI will be defined as children with either (i) Glasgow Coma Scale (GCS) ≤ 8 and an abnormal CT scan or (ii) motor score of ≤ 3 and normal CT scan. Children will be included only if they can be randomised within 6 hours of the injury occurring. Patients will be stratified a priori by (i) centre and (ii) Glasgow Coma Score. One half will be cooled to 32-33°C for 72 hours and then slowly rewarmed. If intracranial hypertension occurs during or after rewarming, the hypothermia group will have cooling continued until intracranial pressure (ICP) is controlled. The other half will have their temperature maintained at 36-37°C. All other aspects of care will be managed with a standardised protocol.
The purpose of this pilot study is to establish the feasibility of doing an outcome study with other international centres. It will also assess the safety of more prolonged cooling and protocol adherence. Primary outcomes will be the frequency of adverse events related to hypothermia, recruitment rates and protocol adherence. These children may also be able to be included in a larger trial.
The primary aim of the outcome study will be to determine whether, in children with severe TBI, prolonged initial hypothermia improves the proportion with good outcome 12 months after injury when compared to initial normothermia. Outcome will be assessed at 6 and 12 months. The primary outcome measure will be a Paediatric Cerebral Performance Category (PCPC) at 12 months after the date of injury, dichotomized to poor outcome (categories 4-6) and good outcome (categories 1-3). Secondary outcome measures will be (i) PCPC at 6 after injury (ii) standardised tests (intelligence and memory, functional outcome, attention, executive functions) 12 months after injury (iii) ICP and cerebral perfusion pressure (CPP) during the first 5 days of treatment (v) frequency and nature of interventions to control ICP/CPP (vi) duration of mechanical ventilation and (vii) potential adverse events.
- Conditions
- Traumatic Brain Injury
- Being tested
- Induced Hypothermia
- Keywords
- Traumatic Brain Injury, Children, Hypothermia, Outcome, Intensive Care, Magnetic resonance Imaging
- Medical subject headings
- Brain Injuries, Traumatic, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced HypothermiaProcedure or surgery
Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric Cerebral Performance Category (PCPC) at 12 months after injury
Measured: 12 months
Recruitment Rates
Measured: Recruitment completion
Adverse Events
Measured: Recruitment completion
Secondary outcomes (4)
Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control
Measured: Recruitment completion
Duration of mechanical ventilation
Measured: Recruitment completion
Intensive care and hospital length of stay
Measured: Recruitment completion
Neuropsychological Outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australia and New Zealand Intensive Care Society
- Sponsor type
- University, hospital or other
- Investigators
- John Beca, FJFICM, Principal investigator, Starship Children's Hospital, Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282269
- Sponsor's protocol ID
- NTX/06/02/002
- Status last verified
- Jun 2009
- First submitted
- 25 Jan 2006
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Early and Prolonged Hypothermia in Severe Traumatic Brain Injury in Children
- ClinicalTrials.gov ID
- NCT00282269
- Acronym / sponsor ID
- NTX/06/02/002
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Children, Hypothermia, Outcome, Intensive Care, Magnetic resonance Imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Australia and New Zealand Intensive Care SocietyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
We propose to do a pilot study of 50 children admitted with severe TBI to paediatric intensive care units in Australia and New Zealand. Severe TBI will be defined as children with either (i) Glasgow Coma Scale (GCS) ≤ 8 and an abnormal CT scan or (ii) motor score of ≤ 3 and normal CT scan. Children will be included only if they can be randomised within 6 hours of the injury occurring. Patients will be stratified a priori by (i) centre and (ii) Glasgow Coma Score. One half will be cooled to 32-33°C for 72 hours and then slowly rewarmed. If intracranial hypertension occurs during or after rewarming, the hypothermia group will have cooling continued until intracranial pressure (ICP) is controlled. The other half will have their temperature maintained at 36-37°C. All other aspects of care will be managed with a standardised protocol.
The purpose of this pilot study is to establish the feasibility of doing an outcome study with other international centres. It will also assess the safety of more prolonged cooling and protocol adherence. Primary outcomes will be the frequency of adverse events related to hypothermia, recruitment rates and protocol adherence. These children may also be able to be included in a larger trial.
The primary aim of the outcome study will be to determine whether, in children with severe TBI, prolonged initial hypothermia improves the proportion with good outcome 12 months after injury when compared to initial normothermia. Outcome will be assessed at 6 and 12 months. The primary outcome measure will be a Paediatric Cerebral Performance Category (PCPC) at 12 months after the date of injury, dichotomized to poor outcome (categories 4-6) and good outcome (categories 1-3). Secondary outcome measures will be (i) PCPC at 6 after injury (ii) standardised tests (intelligence and memory, functional outcome, attention, executive functions) 12 months after injury (iii) ICP and cerebral perfusion pressure (CPP) during the first 5 days of treatment (v) frequency and nature of interventions to control ICP/CPP (vi) duration of mechanical ventilation and (vii) potential adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induced HypothermiaInduced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours | Procedure or surgery | – |
Primary outcome
Paediatric Cerebral Performance Category (PCPC) at 12 months after injury
Time frame: 12 months
Recruitment Rates
Time frame: Recruitment completion
Adverse Events
Time frame: Recruitment completion
4 secondary outcomes
Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control
Time frame: Recruitment completion
Duration of mechanical ventilation
Time frame: Recruitment completion
Intensive care and hospital length of stay
Time frame: Recruitment completion
Neuropsychological Outcome
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Beca, FJFICM principal investigator
Starship Children's Hospital, Auckland, New Zealand
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Induced Hypothermia in people with Traumatic Brain Injury, run by Australia and New Zealand Intensive Care Society at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatric Cerebral Performance Category (PCPC) at 12 months after injury (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.