Neurologic Physiology After Removal of Therapy (NeuPaRT)

NCT ID: NCT05306327

Last Updated: 2024-10-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-18

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Determination of Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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transcranial Doppler (TCD) related (EP), somatosensory (SSEP)

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
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

1. Brain death or plan for Neurologic Determination of Death (NDD)
2. Injuries that anatomically preclude the use of neurologic monitoring
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Centre hospitalier de l'Université de Montréal,

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Teneille Gofton

Role: CONTACT

519-663-2911

Marat Slessarev

Role: CONTACT

519-685-8500 ext. 56560

Facility Contacts

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Andreas Kramer

Role: primary

Julie Kromm

Role: backup

Gord Boyd

Role: primary

Teneille Gofton

Role: primary

519-685-8500 ext. 32911

Marat Slessarev

Role: backup

519-685-8500 ext. 56560

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.

Reference Type DERIVED
PMID: 37105694 (View on PubMed)

Other Identifiers

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Reda 12243

Identifier Type: -

Identifier Source: org_study_id

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