Neurologic Physiology After Removal of Therapy (NeuPaRT)
NCT ID: NCT05306327
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
108 participants
OBSERVATIONAL
2022-10-18
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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electroencephalography (EEG)
1. brain cortical activity using full scalp
2. cerebral blood flow velocity
3. during the dying process following planned withdrawal of life sustaining measures (WLSM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Plan for the withdrawal of life sustaining measures (WLSM)
3. Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures
4. Patient has an indwelling arterial cannula for monitoring blood pressure
Exclusion Criteria
2. Injuries that anatomically preclude the use of neurologic monitoring
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Teneille Gofton, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Locations
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University of Calgary Foothills Campus
Calgary, Alberta, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Centre hospitalier de l'Université de Montréal,
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Andreas Kramer
Role: primary
Julie Kromm
Role: backup
Gord Boyd
Role: primary
Shane English
Role: primary
Sonny Dhanani
Role: backup
Tadeau Fantaneanu
Role: backup
Michaël Chassé
Role: primary
References
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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.
Other Identifiers
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Reda 12243
Identifier Type: -
Identifier Source: org_study_id
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