An observational study in Determination of Death, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Observational
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 158 is below the median of 400 across 236 observational studies indexed under Death.
Browse Death studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Also known as: transcranial Doppler (TCD), related (EP), somatosensory (SSEP)
Patient Accrual complete study procedures)
90 patients at all sites and an additional 18 patients at the lead site for specific tests
Time frame: 2022 to 2023
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.
Time frame: 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.
Time frame: 2022-2023
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After completion of data analysis (5 years after study initiation August 2022)
Started Oct 2022 (actual). Primary completion is estimated for Mar 2027, 53 months after the start.
Of 84 non-industry observational studies under Death, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 245. This study's planned 53 months is below that.
Counting every sponsor, half of 87 studies reached it within 60 months; a quarter within 23 and three quarters within 245.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →