CT-Perfusion for Neurological Diagnostic Evaluation

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.

Conditions

• Neurological Determination of Death

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)

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Michaël Chassé, MD PhD FRCPC · Centre hospitalier de l'Université de Montréal (CHUM)

• Jai JS Shankar, MD MSc FRCPC · University of Manitoba

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-25

Primary Completion

2021-02-22

Completion

2024-08-31

Countries

• Canada

Study Locations