CHIL
The Cerebral Hypothermia in Ischaemic lesion (CHIL) Trial - A Randomised trial evaluating systemic and local mild hypothermia in Acute Ischaemic Stroke
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Status:
Open to recruitment. Recruitment will be put on hold November 2009 and resume late in 2010.
Purpose:
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.
Interventions:
Hypothermia
Reduction of brain temperature and body temperature for neuroprotection
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Location(s):
Australia & China
Year Started:
2009
Design:
Interventional, Randomised controlled trial.
This research program will involve two parallel international trials (both designed as a “proof of concept” randomised controlled trials).
Inclusion Criteria
Clinico-radiological assessment consistent with acute hemispheric ischaemic stroke; presentation within 6 hours of the onset of symptoms or within 6 hours of when last seen unaffected; Perfusion cerebral CT scan demonstrating evidence of hypoperfused but still viable hemispheric brain tissue comprising at least 100% of the hypoperfused “region at risk”; National Institutes of Health Stroke Scale (NIHSS) >= 8; Written informed consent from patient, or if appropriate and approval granted, from Person Responsible.
Exclusion Criteria
Rapidly improving neurological deficit or deficit that has resolved to NIHSS <8 at time of randomisation; Very severe acute stroke syndrome with Middle Cerebral Artery (MCA) plus Anterior Communicating Artery/Posterior Communicating Artery (ACA/PCA) or any acute MCA syndrome where, at the time of assessment, the site chief investigator considers hemicraniectomy may be required within 36 hours from onset; Any intracranial haemorrhage on baseline imaging; Any known serious co-morbid condition likely to complicate therapy such as a history of cardiac failure requiring pharmacotherapy, chronic liver disease, abdominal or pelvic mass causing femoral or inferior vena caval obstruction, Inferior Vena Cava (IVC) filters; Acute pulmonary oedema, respiratory, renal or hepatic failure as judged by the treating physician; Life expectancy < 3 months due to co-morbid conditions; Pre-morbid modified Rankin scale of >2; Pregnancy (women of child bearing potential will have a urine pregnancy test); Known allergy to pethidine.
Patient Involvement:
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.
Primary Outcome:
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 Outcome:
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.
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Source of Information:
Australian New Zealand Clinical Trials Registry
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/14/2009.
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