Hypothermia in Traumatic Brain Injury in Children (HiTBIC)

This study has been completed.
Sponsor:
Information provided by:
Australia and New Zealand Intensive Care Society
ClinicalTrials.gov Identifier:
NCT00282269
First received: January 25, 2006
Last updated: June 18, 2010
Last verified: June 2009
  Purpose

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).

Condition Intervention Phase
Traumatic Brain Injury
Procedure: Induced Hypothermia
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Early and Prolonged Hypothermia in Severe Traumatic Brain Injury in Children

Resource links provided by NLM:


Further study details as provided by Australia and New Zealand Intensive Care Society:

Primary Outcome Measures:
  • Paediatric Cerebral Performance Category (PCPC) at 12 months after injury [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Recruitment Rates [ Time Frame: Recruitment completion ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Recruitment completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control [ Time Frame: Recruitment completion ] [ Designated as safety issue: Yes ]
  • Duration of mechanical ventilation [ Time Frame: Recruitment completion ] [ Designated as safety issue: Yes ]
  • Intensive care and hospital length of stay [ Time Frame: Recruitment completion ] [ Designated as safety issue: Yes ]
  • Neuropsychological Outcome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Induced Hypothermia
    Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282269

Locations
Australia, New South Wales
Royal Alexandra Hospital for Children
Sydney, New South Wales, Australia
Sydney Children's Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Queensland Paediatric Intensive Care Services
Brisbane, Queensland, Australia
Australia, South Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Royal Children's Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Princess Margaret Hospital
Perth, Western Australia, Australia
New Zealand
Starship Children's Hospital
Auckland, New Zealand
Sponsors and Collaborators
Australia and New Zealand Intensive Care Society
Investigators
Principal Investigator: John Beca, FJFICM Starship Children's Hospital, Auckland, New Zealand
  More Information

No publications provided

Responsible Party: Dr Michael Yung, Chair, Paediatric Study Group, Clinical Trials Group, ANZICS
ClinicalTrials.gov Identifier: NCT00282269     History of Changes
Other Study ID Numbers: NTX/06/02/002
Study First Received: January 25, 2006
Last Updated: June 18, 2010
Health Authority: Australia New Zealand: Paediatric Study Group (PSG) of ANZICS Clinical Trials Group (CTG)

Keywords provided by Australia and New Zealand Intensive Care Society:
Traumatic Brain Injury
Children
Hypothermia
Outcome
Intensive Care
Magnetic resonance Imaging

Additional relevant MeSH terms:
Hypothermia
Brain Injuries
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 31, 2014