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ACTIVE NOT RECRUITING
NCT03098511
NA

CT-Perfusion for Neurological Diagnostic Evaluation

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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