Monitoring the brain during warm organ perfusion after withdrawal of life support to confirm no return of blood flow or activity
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 · NCT07423936
This project will use continuous brain monitoring to see if blood flow or brain activity returns when organs are warmed and perfused after death in adults who are donating organs after life support is withdrawn.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07423936 on ClinicalTrials.gov |
What this trial studies
This proof-of-concept observational effort will apply continuous, multimodal neuromonitoring (including measures of cerebral blood flow and neurophysiology) throughout withdrawal of life-sustaining therapy, the dying process, and during abdominal and thoraco‑abdominal normothermic regional perfusion (A‑NRP and TA‑NRP). The study enrolls adults planned for donation after circulatory determination of death within 96 hours and excludes those with significant coagulopathy or on therapeutic anticoagulants to enable safe monitoring. Investigators will document cerebral perfusion and brain electrical activity before, during, and after NRP to determine whether any reperfusion or functional activity reappears under the applied safeguards. The work is conducted at Vancouver General Hospital under University of British Columbia sponsorship to establish feasibility and inform clinical confidence in death determination during organ recovery.
Who should consider this trial
Good fit: Ideal candidates are adults (age >18) who are planned for donation after circulatory death within the next 96 hours and who do not have significant coagulopathy or be receiving therapeutic anticoagulants.
Not a fit: People under 18, those with coagulopathy or on therapeutic anticoagulants, or individuals not undergoing A‑NRP or TA‑NRP would not be eligible and are unlikely to gain direct benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could increase confidence that normothermic regional perfusion does not restore brain blood flow or function, supporting the ethical and safe recovery of organs for transplantation.
How similar studies have performed: There are limited case reports and small series examining brain signals during organ recovery, but comprehensive multimodal monitoring during NRP is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18; 2. Planned DCD within the next 96 hours. Exclusion Criteria: 1. Coagulopathy (International normalized ratio \> 1.5, prothrombin time \> 45 seconds, platelets \< 50); 2. Therapeutic anticoagulant medication administration.
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Study coordinator: Rebecca Grey Clinical Research Coordinator
- Email: cerebri.research@ubc.ca
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion, Normothermic regional perfusion, donation after cardiac death, organ donation