None listed
Conditions
Brief summary
Injuries to the brain that occur after an accident, such as a car crash or after a fall, can be serious and have lasting negative consequences. Estimates suggest that at least 10 million people globally are affected by this type of brain injury every year, known as traumatic brain injury. Those that survive are often left with significant physical and or mental disabilities that are challenging to manage for the patients, their families and the health care system. Prevention of the accidents are important, but it is also important to find treatments that can help the recovery of patients affected by traumatic brain injury. At present there are a limited number of treatments that improve the recovery of these patients. One important area that has promising evidence is temperature control. Our group has contributed to evidence in this area of study. Preliminary evidence suggests that a raised temperature is a very common occurrence and that it may be harmful after traumatic brain injury. Yet, there still remains substantial uncertainty about this finding and whether reducing the patients temperature will help in their recovery. In clinical practice in Australia, cooling treatments are used with substantial variability by doctors, without certainty that the treatment will help the patient recover. Additionally, From our prior research, we know that often the temperature of patients still remains above the normal range, despite the use of cooling treatments. Therefore, we propose a study to work out if it is possible to maintain patient temperature in a targeted low normal range and avoid any elevation of temperature. From our prior work, maintaining temperature in a low normal range is an approach that is used in some centres in Australia. If we are able to maintain temperature in a low normal range successfully, then our plan is to apply for a larger grant to work out if this approach helps with the recovery after traumatic brain injury a study that would help inform the way patients are treated. This larger type of study would require about 1000 patients, but the study that we are seeking to do now only involves 50 patients and is designed to provide practical, preliminary information to enable us to proceed to the next stage.
Interventions
1. If a patient has an initial temperature below 36.0 degrees celsius, the patient will be managed according to the preference of the treating clinician until temperature reaches 36.0 degrees celsius.
2. The intervention will be initiated when temperature reaches 36.0 degrees celsius
3. The aim is to control temperature to 36.0 degrees celsius, with the intention of avoiding any core temperature greater than or equal to 37.0 degrees celsius.
4. The minimum duration is 72 hours following randomi
1. If a patient has an initial temperature below 36.0 degrees celsius, the patient will be managed according to the preference of the treating clinician until temperature reaches 36.0 degrees celsius. 2. The intervention will be initiated when temperature reaches 36.0 degrees celsius 3. The aim is to control temperature to 36.0 degrees celsius, with the intention of avoiding any core temperature greater than or equal to 37.0 degrees celsius. 4. The minimum duration is 72 hours following randomisation or when mechanical ventilation is ceased, whichever occurs first. 5. The intervention may be maintained for as long as is clinically indicated at the discretion of the treating clinician. 6. The choice of intervention (physical cooling device) is at the discretion of the treating clinician. 7. Adherence will be monitored by recording hourly core temperature and use of physical cooling.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 16 2. Blunt trauma with clinical diagnosis of TBI defined as: a. Blunt head trauma b. Glasgow Coma Scale (GCS) score less than or equal to 13 (prior to sedation) c. Computed tomographic (CT) scan of the head consistent with traumatic brain injury 3. Invasive mechanical ventilation and predicted need for invasive mechanical ventilation beyond the next calendar day. 4. Screening and randomisation within 24 hours of injury
Exclusion criteria
1. The treating physician intends to control temperature and/or induce hypothermia as part of the management plan 2. The treating clinician deems participation is not in the patient’s best interests 3. Drug or alcohol intoxication is likely to be the predominant cause of coma 4. Cardiac arrest at scene of injury 5. Spinal cord injury with confirmed neurological deficit 6. Pregnancy 7. Disability prior to injury, defined by a score of 4 or less as assessed by the extended Glasgow Outcome Score 8. Death is deemed to be imminent/inevitable or a treatment limitation order is in place 9. The patient has an underlying process or comorbidity making 180-day survival unlikely
Outcome results
None listed