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The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.
There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors after being declared brain dead.
The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. In donation after circulatory determination of death (DCDD), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process protects donors from suffering and maintains stakeholder trust. In contrast, the current DCDD process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the DCDD process among healthcare and public stakeholders.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroencephalography (EEG) | Diagnostic Test |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Accrual complete study procedures) | 90 patients at all sites and an additional 18 patients at the lead site for specific tests | 2022 to 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Waveform Data Completeness | Adequate waveform signal that (i) spans circulatory arrest, (ii) includes data for at least 80% of the planned observation period (from the withdrawal of life sustaining measures to 30 minutes after circulatory arrest [or 5 minutes for confirmed donation after circulatory determination of death (DCDD) donors]), and (iii) has a clearly identifiable time of cessation for each signal. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include all patients admitted to a participating ICU who fulfil all the inclusion criteria and for whom none of the exclusion criteria exist.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teneille Gofton | Contact | 519-663-2911 | teneille.gofton@lhsc.on.ca | |
| Marat Slessarev | Contact | 519-685-8500 | 56560 | marat.slessarev@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Teneille Gofton, MD MSc FRCPC | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary Foothills Campus | Recruiting | Calgary | Alberta | T2N1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37105694 | Derived | Gofton T, Dhanani S, Meade M, Boyd JG, Chamberlain E, Chandler J, Chasse M, Scales NB, Choi YH, D'Aragon F, Debicki D, English S, Fantaneanu TA, Kramer AH, Kromm J, Murphy N, Norton L, Singh J, Smith MJ, Weijer C, Shemie S, Bentall TC, Campbell E, Slessarev M. Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures. BMJ Open. 2023 Apr 27;13(4):e073643. doi: 10.1136/bmjopen-2023-073643. |
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Requests for data sharing should be directed to the principal investigator (Dr. T. Gofton) and will be considered on a case by case basis and with approval from the Western Health Sciences Research Ethics Board. No video will be shared at any time.
After completion of data analysis (5 years after study initiation August 2022)
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| 2022-2023 |
| Time Difference Circulatory Arrest and Cessation of EEG Activity | Cerebral blood flow velocity in middle cerebral artery (when available), and cessation of event/evoked potentials (LHSC site only). See below for definition of cessation of each signal. | 2022-2023 |
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L2V7 | Canada |
|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5A5 | Canada |
|
| Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
|
| Centre hospitalier de l'Université de Montréal, | Recruiting | Montreal | Quebec | H2X3E4 | Canada |
|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D008919 | Investigative Techniques |