Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
Multimodal NeurOmonitoring During NormOthermic Regional PerFusion for Organ Donors Determined Dead by CircuLatory Criteria fOllowing Withdrawal of Life Sustaining Measures (NONOFLOW): A Proof-of-Concept Study
University of British Columbia
30 participants
Feb 24, 2025
OBSERVATIONAL
Conditions
Summary
The aim of this study is to demonstrate that cerebral blood flow and brain function do not resume after death declaration in organ donors who undergo normothermic regional perfusion to restore organ function following death determination by circulatory criteria, when appropriate safeguards are applied. To assess the absence of cerebral perfusion and function, investigators will use continuous and comprehensive multimodal neuromonitoring throughout the withdrawal of life-sustaining therapies, the dying process and the NRP procedure.
Eligibility
Inclusion Criteria2
- Age > 18;
- Planned DCD within the next 96 hours.
Exclusion Criteria2
- Coagulopathy (International normalized ratio > 1.5, prothrombin time > 45 seconds, platelets < 50);
- Therapeutic anticoagulant medication administration.
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Interventions
Neuromonitoring during withdrawal of life sustaining therapies, dying process and during normothermic regional perfusion after death. The neuromonitoring will include: * Invasive intracranial pressure monitoring (Codman) * Bilateral invasive oxygentation monitoring (Licox) * Bilateral invasive blood flow monitoring (Hemedex) * Bilateral invasive EEG monitoring (Nantus) * Cerebral microdialysis * Transcranial doppler (Novosignal) * Jugular bulb oximetry (Edwards) * Surface EEG (Nantus) * Near infrared spectroscopy (Masimo) * Somatosensory and brainstem evoked potentials * Bispectral index (Masimo)
Locations(1)
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NCT07423936