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

NCT07423936 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Organ Preservation
  • Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion

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)

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423936 on ClinicalTrials.gov