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

February 13, 2026 updated by: Myp Sekhon, University of British Columbia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consented eligible organ donors

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consented Organ Donors
Consented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function)
Time Frame: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion

To determine the presence or absence of the brain circulation and function during normothermic regional perfusion assessed by intra-parenchymal neuromonitoring, non-invasive neuromonitoring and clinical examination.

Reperfusion or regain of brain function during normothermic regional perfusion will be expressed in proportion.

Restoration of either cerebral perfusion or neurological function in a patient will be considered a single brain reanimation event.

Clinical examination will consist of serial pupillary light reflex assessment and monitoring for respiratory efforts during normothermic regional perfusion.

Evidence of brain function will be determined by the presence of rhythmic delta wave activity on electroencephalography, N20 response with somatosensory evoked potentials or presence of brainstem auditory evoked potentials.

Restoration of brain circulation will be determined by the presence of cerebral blood flow (>10mls/100g/min) or brain tissue oxygen tension (>2mmHg).
One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
Aim 2: Feasibility of conducting multimodal monitoring
Time Frame: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion

To assess the feasibility of implementing multimodal neuromonitoring in DCD organ donors undergoing normothermic regional perfusion.

This will be a descriptive outcome in which investigators will calculate the duration of available data for each modality and compare it with the total observation period.

The investigators hypothesized that feasibility will be strong and that > 80% data variables will be collected for the pre-specified duration in each case.
One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 3: To assess the agreement between invasive and non-invasive neuromonitoring in determining the presence or absence of brain reanimation during normothermic regional perfusion.
Time Frame: During normothermic regional perfusion
To assess the agreement between invasive (intra-parenchymal cerebral blood flow, intra-parenchymal brain oxygenation, invasive EEG) and non invasive neuromonitoring (transcranial doppler, surface EEG, brainstem auditory evoked potentials, somatosensory evoked potentials) in determining the presence of brain circulation and function during normothermic regional perfusion
During normothermic regional perfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H24-00788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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