Organ TransplantCONCLUDENCT05884736
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
An observational study of Organ Transplant, run by Western University, Canada at 2 sites in Canada.
Trial summary
This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Organ Transplant
- What is being tested?
- Neuromonitoring
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Apr 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in critical care at participating study centers who qualify for DCC organ donation and whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs.
Who may be able to join
- ≤ 18 years of age
- Potential DCC donors whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs. These may include patients donating a liver, kidneys, pancreas, and/or lungs; please see Appendix A for organ specific donor inclusion criteria.
Who cannot join
- < 18 years of age
- DCC donors who proceed to donation following medical assistance in dying or those who are able to provide first-person consent at the time of donation
- Injuries that anatomically preclude the use of neurological monitoring
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Crystal Engelage, PhD, 519-685-8500 ext. 37517, Crystal.Engelage@lhsc.on.ca
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Erin Winter, HBSc, 416-340-4800 ext. 6093, Erin.Winter@uhn.ca
Markus Selzner, MD
About this study
Official title: Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria
This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. This will be assessed using multimodal neuromonitoring protocol that enables continuous focused monitoring of brain blood flow and activity during A-NRP. This will provide evidence that brain blood flow and activity does not resume during NRP and ensure donor safety in using this technique in standard of care practice.
Read the detailed description
This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities:
- Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,
- Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and
- Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity.
The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario.
- Conditions
- Organ Transplant
- Being tested
- Neuromonitoring
- Keywords
- A-NRP, neuromonitoring, brain activity, transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromonitoringOther
Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)
| Study group | Role | What they receive |
|---|---|---|
| DCC Donors | Standard criteria DCC donors will be undergoing the A-NRP perfusion process to recondition organs prior to procurement. Multimodal neuromonitors will be placed on the donor prior to withdrawal of life support and readings will be recorded during the withdrawal process and for the duration of the A-NRP perfusion process. The neuromonitoring team will be looking for evidence of brain blood flow or activity. Receives: Other: Neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor resumption of brain blood flow and/or activity
Proportion of enrolled patients who have resumption of brain blood flow and/or activity during A-NRP on any neuromonitor and that is confirmed by neurocritical care physician and that results in termination of A-NRP
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Donor accrual rate
Number of eligible donors who are enrolled in the study and complete study procedures
Measured: Through study completion, an average of 1 year
Consent rate
Number of donors who consent to study procedures divided by the number of donors approached for study consent (target ≥ 80%)
Measured: Through study completion, an average of 1 year
Neuromonitoring modalities
Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities
Measured: Through study completion, an average of 1 year
Duration and proportion of neuromonitoring signal
Duration of continuous neuromonitoring and proportion of total recording time with adequate signal per patient (velocity waveforms for TCCD, uv/mm for EEG, brainstem auditory evoked potentials (BAEP) signal, and somatosensory evoked potentials (SSEP) signal)
Measured: Through study completion, an average of 1 year
Neuromonitoring failure
Proportion of enrolled patients who had failure of neuromonitoring equipment during recording
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start2 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Anton Skaro, Western University, Canada
- Investigators
- Anton Skaro, MD PhD, Principal investigator, London Health Sciences Centre/Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884736
- Sponsor's protocol ID
- 4436
- Acronym
- CONCLUDE
- Status last verified
- May 2026
- First submitted
- 16 May 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria
- ClinicalTrials.gov ID
- NCT05884736
- Acronym / sponsor ID
- CONCLUDE / 4436
- Conditions
- Organ Transplant
- Keywords
- A-NRP, neuromonitoring, brain activity, transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. This will be assessed using multimodal neuromonitoring protocol that enables continuous focused monitoring of brain blood flow and activity during A-NRP. This will provide evidence that brain blood flow and activity does not resume during NRP and ensure donor safety in using this technique in standard of care practice.
Detailed description
This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities:
- Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,
- Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and
- Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity.
The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCC Donors | – | Other: NeuromonitoringStandard criteria DCC donors will be undergoing the A-NRP perfusion process to recondition organs prior to procurement. Multimodal neuromonitors will be placed on the donor prior to withdrawal of life support and readings will be recorded during the withdrawal process and for the duration of the A-NRP perfusion process. The neuromonitoring team will be looking for evidence of brain blood flow or activity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in critical care at participating study centers who qualify for DCC organ donation and whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs.
Key inclusion criteria (2 listed)
- ≤ 18 years of age
- Potential DCC donors whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs. These may include patients donating a liver, kidneys, pancreas, and/or lungs; please see Appendix A for organ specific donor inclusion criteria.
Key exclusion criteria (3 listed)
- < 18 years of age
- DCC donors who proceed to donation following medical assistance in dying or those who are able to provide first-person consent at the time of donation
- Injuries that anatomically preclude the use of neurological monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuromonitoringMultimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP) | Other | DCC Donors |
Primary outcome
Donor resumption of brain blood flow and/or activity
Time frame: Through study completion, an average of 1 year
Proportion of enrolled patients who have resumption of brain blood flow and/or activity during A-NRP on any neuromonitor and that is confirmed by neurocritical care physician and that results in termination of A-NRP
5 secondary outcomes
Donor accrual rate
Time frame: Through study completion, an average of 1 year
Consent rate
Time frame: Through study completion, an average of 1 year
Neuromonitoring modalities
Time frame: Through study completion, an average of 1 year
Duration and proportion of neuromonitoring signal
Time frame: Through study completion, an average of 1 year
Neuromonitoring failure
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anton Skaro, MD PhD principal investigator
London Health Sciences Centre/Lawson Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplant, run by Western University, Canada at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Engelage, PhD (519-685-8500 ext. 37517, Crystal.Engelage@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor resumption of brain blood flow and/or activity (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.