Determination of DeathNeuPaRTNCT05306327
Neurologic Physiology After Removal of Therapy (NeuPaRT)
An observational study of Determination of Death, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Determination of Death
- What is being tested?
- electroencephalography (EEG)
- How many people
- 158 participants
- Where
- 5 sitesCanada
- Study dates
- 18 Oct 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Brain death or plan for Neurologic Determination of Death (NDD)
- Injuries that anatomically preclude the use of neurologic monitoring
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
University of Calgary Foothills Campus
Calgary, Alberta, T2N1N4
Andreas Kramer
Julie Kromm
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
Gord Boyd
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Teneille Gofton, 519-685-8500 ext. 32911, teneille.gofton@lhsc.on.ca
Marat Slessarev, 519-685-8500 ext. 56560, marat.slessarev@lhsc.on.ca
- Recruiting
Centre hospitalier de l'Université de Montréal,
Montreal, Quebec, H2X3E4
Michaël Chassé
- Recruiting
Ottawa Hospital
Ottawa, Ontario, K1H8L6
Shane English
Sonny Dhanani
About this study
Official title: Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study
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.
Read the detailed description
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
- Determination of Death
- Being tested
- electroencephalography (EEG)
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography (EEG)Diagnostic test
Also called transcranial Doppler (TCD), related (EP), somatosensory (SSEP)
- brain cortical activity using full scalp
- cerebral blood flow velocity
- during the dying process following planned withdrawal of life sustaining measures (WLSM)
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Accrual complete study procedures)
90 patients at all sites and an additional 18 patients at the lead site for specific tests
Measured: 2022 to 2023
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start18 Oct 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Determination of DeathStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teneille Gofton, MD MSc FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306327
- Sponsor's protocol ID
- Reda 12243
- Acronym
- NeuPaRT
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37105694
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study
- ClinicalTrials.gov ID
- NCT05306327
- Acronym / sponsor ID
- NeuPaRT / Reda 12243
- Conditions
- Determination of Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Brain death or plan for Neurologic Determination of Death (NDD)
- Injuries that anatomically preclude the use of neurologic monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalography (EEG)Also: transcranial Doppler (TCD), related (EP), somatosensory (SSEP)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) | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Waveform Data Completeness
Time frame: 2022-2023
Time Difference Circulatory Arrest and Cessation of EEG Activity
Time frame: 2022-2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 37105694Gofton 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teneille Gofton, MD MSc FRCPC principal investigator
London Health Sciences Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determination of Death, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teneille Gofton (519-663-2911, teneille.gofton@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Accrual complete study procedures) (time frame: 2022 to 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.