To examine whether mild hypothermia, administered either by systemic (Australian trial) or local head cooling (Chinese trial) attenuates infarct expansion and salvages penumbral brain tissue using imaging outcome parameters.
- Hypothermia Device
Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection
Interventional, Randomised controlled trial. This research program will involve two parallel international trials (both designed as a “proof of concept” randomised controlled trials).
The patient's rectal core temperature is monitored and provides a feedback system to the cooling system to maintain target temperature and control rewarming. the patient is cooled at 33 degrees for 24 hours and is rewarmed slowly to 37 degrees over 12 hours. Participants who are randomised to normothermia receive active routine care in the Acute Stroke Unit. Temperature is to be kept less than 38 degrees as per usual treatment post acute stroke. Baseline CT scan and clinical assessment is attended on patients when first admitted to the emergency department. The CT scan is repeated 30 days post stroke to observe the outcome. The participant clinical outcome follow-up measures are attended 90 days post stroke.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Infarct expansion and penumbral salvage: Mean percent penumbral salvage from baseline computerised tomography (CT)scan confirming acute Middle Cerebral Artery Ischaemic stroke to 30 day computerised tomography scan, hypothermia versus normothermia groups. Penumbral salvage is defined as tissue salvaged/tissue at risk in terms of lesion volume.|
|Secondary||Safety and Clinical: Mortality, neurological deterioration as measured by a decline in the National Institute of Health Stroke Scale(NIHSS) of 4 points or more, catheter related complications, infective complications and thromboembolic complications in addition to all other events fulfilling standard definitions of adverse and serious events will be monitored and documented. The NIHSS will be performed at baseline, 24 hours, 7 days as well as any time a clinical neurological deterioration is suspected. A standard battery of clinical outcome measures will be performed at 90 days - NIHSS, modified rankin scale(mRS), and Barthel Index(BI). Favourable outcomes will be defined as mRS < 3, BI >90, NIHSS < 4.|