Trials / Recruiting
RecruitingNCT07423936
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- University of British Columbia · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This will be a proof-of-concept study aimed at establishing the feasibility of multimodal neuromonitoring in patient undergoing abdominal (A-NRP) and thoraco-abdominal (TA-NRP) and to investigate whether resumption of CBF or function occurs in a cohort of DCD organ donors during A-NRP and TA-NRP. A central goal of this study is to demonstrate the absence of cerebral blood flow and function following normothermic regional perfusion, thereby improving clinical confidence to its safety and maintenance of adherence to death determination in organ donors.
Conditions
- Organ Preservation
- Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2025-02-24
- Primary completion
- 2028-09-01
- Completion
- 2028-12-01
- First posted
- 2026-02-20
- Last updated
- 2026-02-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT07423936. Inclusion in this directory is not an endorsement.