None listed
Conditions
Brief summary
Traumatic brain injury (TBI) is a leading cause of death and long term disability, particularly in young adults. Studies from Australia have shown that approximately half of those with severe traumatic brain injury will be severely disabled or dead 6 months post injury. Given the young age of many patients with severe TBI and the long term prevalence of major disability, the economic and more importantly the social cost to the community is very high. Pre-hospital and hospital management of patients with severe brain injury focuses on prevention of additional injury due primarily to lack of oxygen and insufficient blood pressure. This includes optimising sedation & ventilation, maintaining the fluid balance and draining Cerebrospinal Fluid (CSF) & performing surgery where appropriate. In recent years there has been a research focus on specific pharmacologic interventions however to date there has been no treatment that has been associated with improvement of neurological outcomes. One treatment that shows promise is the application of hypothermia (cooling). This treatment is commonly used in Australia to decrease brain injury in patients with brain injury following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a number of mechanisms. There have been a number of animal studies that have looked at how cooling is protective and also some clinical research that suggests some benefit. However at the current time there is insufficient evidence to provide enough proof that cooling should be used routinely for patients with brain injury and like all treatments there can be some risks and side effects. The POLAR trial has been developed to investigate whether early cooling of patients with severe traumatic brain injury is associated with better outcomes. It is a randomised controlled trial, which is a type of trial that provides the highest quality of evidence.
Interventions
Early and sustained hypothermia. Hypothermia will initially be induced by infusion of up to 2L ice cold saline. Following a safety assessment the patient will be rapidly cooled to 33C using surface temperature control equipment. They will be maintained at 33C for 72hours. Slow rewarming will occur at a rate of 1C/4hrs and will be titrated to intracranial pressure (ICP) control and blood pressure.
Sponsors
Australian and New Zealand Intensive Care-Research Centre, Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Pre-hospital Inclusion Criteria *Blunt trauma with clinical diagnosis of severe Traumatic Brain Injury (TBI) and Glasgow Coma Scale <9 *Estimated age = 18 and < 60 years of age *The patient is intubated or intubation is imminent Emergency Dept Inclusion Criteria *Blunt trauma with clinical diagnosis of severe TBI and GCS <9 *Estimated age > or = 18 and < 60 years of age *The patient is intubated or intubation is imminent
Exclusion criteria
***********Pre-hospital Exclusion Criteria Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma Randomisation unable to be performed within 3 hrs of estimated time of injury Estimated transport time to study hospital >2.5hrs Able to be intubated without drugs Systolic BP <90mmHg Heart rate > 120bpm Cardiac arrest at the scene or in transit GCS=3 and un-reactive pupils Penetrating neck/torso injury Known or obvious pregnancy Receiving hospital is not a study site Evidence of current anti-coagulant treatment Known to be carer dependent due to a pre-existing neurological condition ***********Emergency Dept Exclusion Criteria Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma Randomisation unable to be performed within 3 hrs of estimated time of injury Able to be intubated without drugs Persistent Systolic BP <90mmHg GCS=3 + un-reactive pupils Cardiac arrest at the scene or in transit Clinically significant bleeding likely to require haemostatic intervention, for example: Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolisation **Pelvic fracture likely to require surgery +/- embolisation **More than two long bone fractures requiring operative fixation **Penetrating neck/torso injury Positive urine or blood pregnancy test Evidence of current anti-coagulant treatment Known to be carer dependent due to a pre-existing neurological condition In the treating clinician’s opinion, “cooling” is not in the patient’s best interest
Outcome results
None listed