Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282269
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2006-01-25
Brief Title:
Hypothermia in Traumatic Brain Injury in Children HiTBIC
Sponsor:
Australia and New Zealand Intensive Care Society
Organization:
Australia and New Zealand Intensive Care Society
Study Overview
Official Title:
Pilot Study of Early and Prolonged Hypothermia in Severe Traumatic Brain Injury in Children
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 32-33C 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 36-37C 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 ICPCPP vi duration of mechanical ventilation and vii potential adverse events
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 ICPCPP vi duration of mechanical ventilation and vii potential adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None