NCT00282269

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Typical duration for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2009

Enrollment Period

3.6 years

First QC Date

January 25, 2006

Last Update Submit

June 18, 2010

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryChildrenHypothermiaOutcomeIntensive CareMagnetic resonance Imaging

Outcome Measures

Primary Outcomes (3)

  • Paediatric Cerebral Performance Category (PCPC) at 12 months after injury

    12 months

  • Recruitment Rates

    Recruitment completion

  • Adverse Events

    Recruitment completion

Secondary Outcomes (4)

  • Intracranial pressure(ICP)/Cerebral perfusion pressure(CPP) control

    Recruitment completion

  • Duration of mechanical ventilation

    Recruitment completion

  • Intensive care and hospital length of stay

    Recruitment completion

  • Neuropsychological Outcome

    12 months

Interventions

Induced HypothermiaPROCEDURE

Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Alexandra Hospital for Children

Sydney, New South Wales, Australia

Location

Sydney Children's Hospital

Sydney, New South Wales, Australia

Location

Queensland Paediatric Intensive Care Services

Brisbane, Queensland, Australia

Location

Women's and Children's Hospital

Adelaide, South Australia, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, Australia

Location

Princess Margaret Hospital

Perth, Western Australia, Australia

Location

Starship Children's Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticHypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • John Beca, FJFICM

    Starship Children's Hospital, Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 26, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 22, 2010

Record last verified: 2009-06

Locations

AU(6)NZ(1)