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NCT Number: NCT05306327

Neurologic Physiology After Removal of Therapy (NeuPaRT)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary Foothills Campus, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Plan for the withdrawal of life sustaining measures (WLSM)
  • Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures
  • Patient has an indwelling arterial cannula for monitoring blood pressure

Exclusion criteria

  • Brain death or plan for Neurologic Determination of Death (NDD)
  • Injuries that anatomically preclude the use of neurologic monitoring

Treatment and study plan

Electroencephalography (EEG)

Diagnostic Test
  • brain cortical activity using full scalp
  • cerebral blood flow velocity
  • during the dying process following planned withdrawal of life sustaining measures (WLSM)

Other names: transcranial Doppler (TCD), related (EP), somatosensory (SSEP)

Primary outcomes

  1. Patient Accrual complete study procedures)

    Time frame: 2022 to 2023

    90 patients at all sites and an additional 18 patients at the lead site for specific tests

Secondary outcomes

  1. Waveform Data Completeness

    Time frame: 2022-2023

    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.

  2. Time Difference Circulatory Arrest and Cessation of EEG Activity

    Time frame: 2022-2023

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marat Slessarev

CONTACT

[email protected]

519-685-8500 ext. 56560

Teneille Gofton

CONTACT

[email protected]

519-663-2911

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study

Acronym: NeuPaRT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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