The Cerebral Hypothermia in Ischaemic lesion (CHIL) Trial - A Randomised trial evaluating systemic and local mild hypothermia in Acute Ischaemic Stroke "CHIL"
Recruiting
Phase N/A Results N/AEligibility Criteria
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.Recruitment
- Gender: Both
- Minimum Age: 18
- Study Size: 3
- Study Size Planned: 80
- Number of Centers Planned: 1
- Max Time from Onset: 6 Hours
Principal Investigator
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Professor Christopher Levi
Hunter Stroke Research Group John Hunter Hospital Locked Bag 1 Hunter Region mail Centre NSW 2310 Australia Tel: +61 2 49 855593 Fax: +61 2 49214838 Email: christopher.levi@hnehealth.nsw.gov.au
Locations
- Australia & China