Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hypothermia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

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).
    

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.
    

Intervention name(s): Induced Hypothermia
Intervention type(s): Procedure
Intervention description(s): Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Children; Hypothermia; Outcome; Intensive Care; Magnetic resonance Imaging