Neuromonitoring Study During Normothermic Regional Perfusion in Organ Donors Declared Dead by Circulatory Criteria After Life Support Withdrawal
Led by University of British Columbia · Updated on 2026-02-20
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to study organ donors who have been declared dead by circulatory criteria after withdrawal of life-sustaining measures. The goal is to confirm that cerebral blood flow and brain function do not return during normothermic regional perfusion, a process used to restore organ function after death. This study will improve understanding about the safety and adherence to death determination in these donors.
Participants will undergo continuous and detailed neuromonitoring during the withdrawal of life support, the dying process, and the normothermic regional perfusion procedure. The neuromonitoring includes invasive and non-invasive methods such as intracranial pressure monitoring, oxygenation and blood flow measurements, EEG, cerebral microdialysis, transcranial Doppler, jugular bulb oximetry, near infrared spectroscopy, evoked potentials, and bispectral index monitoring.
Throughout the study, monitoring will be performed starting one hour before life support withdrawal, continuing through the dying process, and for two hours during normothermic regional perfusion. Researchers will assess the absence of brain circulation and function, evaluate the feasibility of using multimodal monitoring, and compare invasive and non-invasive neuromonitoring methods. The total participation time varies depending on individual timing of withdrawal and perfusion procedures.
CONDITIONS
Brief Title
Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
Research Team
R
Rebecca Grey Clinical Research Coordinator
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Participants are screened for eligibility to participate in the trial.
Neuromonitoring During Withdrawal and Dying Process
Duration - Approximately 1 hour prior to withdrawal plus variable dying duration
Participants undergo multimodal neuromonitoring starting one hour prior to withdrawal of life-sustaining therapies and continuing through the dying process.
1 monitoring period (continuous)
Neuromonitoring During Normothermic Regional Perfusion
Duration - 2 hours
Participants continue to receive multimodal neuromonitoring for 2 hours during normothermic regional perfusion to assess brain circulation and function.
1 monitoring period (continuous)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Maintaining the permanence principle for death during in situ normothermic regional perfusion for donation after circulatory death organ recovery: A United Kingdom and Canadian proposal.
Protocol for a qualitative pilot study to explore ethical issues and stakeholder trust in the use of normothermic regional perfusion in organ donation in Canada.
Nicholas Murphy, Lorelei Lingard, Laurie Blackstock...
Outcomes of Controlled Donation After Cardiac Death Compared With Donation After Brain Death in Liver Transplantation: A Systematic Review and Meta-analysis.
A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: a 2023 clinical practice guideline.