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CT-Perfusion for Neurological Diagnostic Evaluation
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
For the purpose of organ donation after neurological determination of death (NDD), death must be declared using a set of standardized clinical criteria. When a full clinical evaluation cannot be completed, additional neuroimaging ancillary testing is required. The ideal ancillary test for NDD would demonstrate no cerebral blood flow, be free of false-positive and false negative results, rapid, safe, readily available, non-invasive, and inexpensive. No current ancillary test for NDD meets these criteria. Computed tomography (CT) perfusion has the characteristics of an ideal test for NDD, but has not been evaluated for routine clinical use for NDD. The overarching goal of this project is to improve the NDD process by establishing CT-perfusion as the ideal ancillary test. A large prospective Canadian multi-centre diagnostic cohort study will be conducted to validate CT-perfusion for the neurological determination of death. Specific objectives are: Primary objective: To determine diagnostic accuracy of CT-perfusion compared to complete clinical evaluation for NDD. Secondary objectives: 1) To confirm the safety of performing CT-perfusion in critically ill patients suspected of being neurologically deceased; 2) To establish the CT-perfusion inter-rater reliability for NDD; 3) To evaluate the diagnostic accuracy of CT-angiography compared to complete clinical evaluation and to CT-perfusion for NDD; 4) To describe the clearance of commonly used sedatives and narcotics in the setting of NDD; and 5) to investigate biological changes (inflammatory and nanovesicles) that occur in humans during the brain dying process.
Official title: CT-Perfusion for Neurological Diagnostic Evaluation: a Prospective Canadian Multicenter Diagnostic Test Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2017-04-25
Completion Date
2024-08-31
Last Updated
2024-04-23
Healthy Volunteers
No
Conditions
Interventions
Neurological Diagnostic Evaluation
Clinical Data: * Demographic data * Daily data (clinical exams, laboratory data) * Drug administration * Additional clinical or ancillary neurological determination test Diagnostic Intervention: * CT-Perfusion * CT-Angiography reconstructions Reference Standard: \- Clinical Neurological Exam Blood Samples (Pharmacokinetics, Inflammatory \& Nanovesicles Parameters): * At the time of patient enrolment * 6 hours after patient enrolment * At the time of the clinical neurological exam Secondary Outcome measures at 6 months: * extended Glasgow Outcome Scale (GOSe) * modified Rankin Scale (mRS)
Locations (14)
Foothills Medical Centre
Calgary, Alberta, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
William Osler Health System
Brampton, Ontario, Canada
Hamilton Health Sciences Center
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St-Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada