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RECRUITING
NCT07423936

Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-02-24

Completion Date

2028-12

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

OTHER

Neuromonitoring

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)

Vancouver General Hospital

Vancouver, British Columbia, Canada