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Neurologic Physiology After Removal of Therapy (NeuPaRT)

L

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

Status

Enrolling

Conditions

Determination of Death

Treatments

Diagnostic Test: electroencephalography (EEG)

Study type

Observational

Funder types

Other

Identifiers

NCT05306327
Reda 12243

Details and patient eligibility

About

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.

Full 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.

Enrollment

158 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

5

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Central trial contact

Teneille Gofton; Marat Slessarev

Data sourced from clinicaltrials.gov

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