Organ PreservationNONOFLOWNCT07423936
Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
An observational study of Organ Preservation and Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
- What is being tested?
- Neuromonitoring
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2025to Dec 2028
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consented eligible organ donors
Who may be able to join
- Age > 18;
- Planned DCD within the next 96 hours.
Who cannot join
- Coagulopathy (International normalized ratio > 1.5, prothrombin time > 45 seconds, platelets < 50);
- Therapeutic anticoagulant medication administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Mypinder Sekhon, 604-875-5949, myp@mail.ubc.ca
About this study
Official title: 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.
Read the 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
- Being tested
- Neuromonitoring
- Keywords
- Normothermic regional perfusion, donation after cardiac death, organ donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromonitoringOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Consented Organ Donors | Consented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours. Receives: Other: Neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function)
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).
Measured: 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
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.
Measured: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
Secondary outcomes (1)
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.
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
Measured: During normothermic regional perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Feb 2025
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Organ PreservationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myp Sekhon, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423936
- Sponsor's protocol ID
- H24-00788
- Acronym
- NONOFLOW
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murphy N, Lingard L, Blackstock L, Ott M, Slessarev M, Basmaji J, Brahmania M, Healey A, Shemie S, Skaro A, Wilson L, Weijer C. Protocol for a qualitative pilot study to explore ethical issues and stakeholder trust in the use of normothermic regional perfusion in organ donation in Canada. BMJ Open. 2022 Sep 29;12(9):e067515. doi: 10.1136/bmjopen-2022-067515.
PubMed 36175093Murphy NB, Weijer C, Slessarev M, Chandler JA, Gofton T. Implications of the updated Canadian Death Determination Guidelines for organ donation interventions that restore circulation after determination of death by circulatory criteria. Can J Anaesth. 2023 Apr;70(4):591-595. doi: 10.1007/s12630-023-02413-6. Epub 2023 May 2. No abstract available.
PubMed 37131028Shemie SD, Wilson LC, Hornby L, Basmaji J, Baker AJ, Bensimon CM, Chandler JA, Chasse M, Dawson R, Dhanani S, Mooney OT, Sarti AJ, Simpson C, Teitelbaum J, Torrance S, Boyd JG, Brennan J, Brewster H, Carignan R, Dawe KJ, Doig CJ, Elliott-Pohl K, Gofton TE, Hartwick M, Healey A, Honarmand K, Hornby K, Isac G, Kanji A, Kawchuk J, Klowak JA, Kramer AH, Kromm J, LeBlanc AE, Lee-Ameduri K, Lee LA, Leeies M, Lewis A, Manara A, Matheson S, McKinnon NKA, Murphy N, Briard JN, Pope TM, Sekhon MS, Shanker JJS, Singh G, Singh J, Slessarev M, Soliman K, Sutherland S, Weiss MJ, Shaul RZ, Zuckier LS, Zorko DJ, Rochwerg B. A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: a 2023 clinical practice guideline. Can J Anaesth. 2023 Apr;70(4):483-557. doi: 10.1007/s12630-023-02431-4. Epub 2023 May 2.
PubMed 37131020Shapey IM, Summers A, Augustine T, van Dellen D. Systematic review to assess the possibility of return of cerebral and cardiac activity after normothermic regional perfusion for donors after circulatory death. Br J Surg. 2019 Feb;106(3):174-180. doi: 10.1002/bjs.11046. Epub 2019 Jan 22.
PubMed 30667536Peled H, Mathews S, Rhodes D, Bernat JL. Normothermic Regional Perfusion Requires Careful Ethical Analysis Before Adoption Into Donation After Circulatory Determination of Death. Crit Care Med. 2022 Nov 1;50(11):1644-1648. doi: 10.1097/CCM.0000000000005632. Epub 2022 Oct 13. No abstract available.
PubMed 36227032Manara A, Shemie SD, Large S, Healey A, Baker A, Badiwala M, Berman M, Butler AJ, Chaudhury P, Dark J, Forsythe J, Freed DH, Gardiner D, Harvey D, Hornby L, MacLean J, Messer S, Oniscu GC, Simpson C, Teitelbaum J, Torrance S, Wilson LC, Watson CJE. Maintaining the permanence principle for death during in situ normothermic regional perfusion for donation after circulatory death organ recovery: A United Kingdom and Canadian proposal. Am J Transplant. 2020 Aug;20(8):2017-2025. doi: 10.1111/ajt.15775. Epub 2020 Jan 27.
PubMed 31922653van de Leemkolk FEM, Schurink IJ, Dekkers OM, Oniscu GC, Alwayn IPJ, Ploeg RJ, de Jonge J, Huurman VAL. Abdominal Normothermic Regional Perfusion in Donation After Circulatory Death: A Systematic Review and Critical Appraisal. Transplantation. 2020 Sep;104(9):1776-1791. doi: 10.1097/TP.0000000000003345.
PubMed 32541563Shapey IM, Muiesan P. Regional perfusion by extracorporeal membrane oxygenation of abdominal organs from donors after circulatory death: a systematic review. Liver Transpl. 2013 Dec;19(12):1292-303. doi: 10.1002/lt.23771.
PubMed 24136827Hessheimer AJ, de la Rosa G, Gastaca M, Ruiz P, Otero A, Gomez M, Alconchel F, Ramirez P, Bosca A, Lopez-Andujar R, Atutxa L, Royo-Villanova M, Sanchez B, Santoyo J, Marin LM, Gomez-Bravo MA, Mosteiro F, Villegas Herrera MT, Villar Del Moral J, Gonzalez-Abos C, Vidal B, Lopez-Dominguez J, Llado L, Roldan J, Justo I, Jimenez C, Lopez-Monclus J, Sanchez-Turrion V, Rodriguez-Laiz G, Velasco Sanchez E, Lopez-Baena JA, Caralt M, Charco R, Tome S, Varo E, Marti-Cruchaga P, Rotellar F, Varona MA, Barrera M, Rodriguez-Sanjuan JC, Briceno J, Lopez D, Blanco G, Nuno J, Pacheco D, Coll E, Dominguez-Gil B, Fondevila C. Abdominal normothermic regional perfusion in controlled donation after circulatory determination of death liver transplantation: Outcomes and risk factors for graft loss. Am J Transplant. 2022 Apr;22(4):1169-1181. doi: 10.1111/ajt.16899. Epub 2021 Dec 21.
PubMed 34856070Basmaji J, Weijer C, Skaro A, Healey A, Shemie SD, Slessarev M. Paving the Road for the Adoption of Normothermic Regional Perfusion in Canada. Crit Care Explor. 2021 Oct 28;3(11):e0553. doi: 10.1097/CCE.0000000000000553. eCollection 2021 Nov.
PubMed 34729491Ivanics T, Shwaartz C, Claasen MPAW, Patel MS, Yoon P, Raschzok N, Wallace D, Muaddi H, Murillo Perez CF, Hansen BE, Selzner N, Sapisochin G. Trends in indications and outcomes of liver transplantation in Canada: A multicenter retrospective study. Transpl Int. 2021 Aug;34(8):1444-1454. doi: 10.1111/tri.13903. Epub 2021 Jul 7.
PubMed 33977568Schaapherder A, Wijermars LGM, de Vries DK, de Vries APJ, Bemelman FJ, van de Wetering J, van Zuilen AD, Christiaans MHL, Hilbrands LH, Baas MC, Nurmohamed AS, Berger SP, Alwayn IP, Bastiaannet E, Lindeman JHN. Equivalent Long-term Transplantation Outcomes for Kidneys Donated After Brain Death and Cardiac Death: Conclusions From a Nationwide Evaluation. EClinicalMedicine. 2018 Oct 9;4-5:25-31. doi: 10.1016/j.eclinm.2018.09.007. eCollection 2018 Oct-Nov.
PubMed 31193600Bleszynski MS, Parmentier C, Torres-Hernandez A, Ray S, Yousuf A, Norgate A, Schiff J, Shwaartz C, Sapisochin G, McGilvray I, Selzner M, Reichman TW. Pancreas transplantation with grafts obtained from donation after cardiac death or donation after brain death results in comparable outcomes. Front Transplant. 2023 Aug 9;2:1176398. doi: 10.3389/frtra.2023.1176398. eCollection 2023.
PubMed 38993888Palleschi A, Rosso L, Musso V, Rimessi A, Bonitta G, Nosotti M. Lung transplantation from donation after controlled cardiocirculatory death. Systematic review and meta-analysis. Transplant Rev (Orlando). 2020 Jan;34(1):100513. doi: 10.1016/j.trre.2019.100513. Epub 2019 Oct 18.
PubMed 31718887Haque OJ, Roth EM, Fleishman A, Eckhoff DE, Khwaja K. Long-Term Outcomes of Early Experience in Donation After Circulatory Death Liver Transplantation: Outcomes at 10 Years. Ann Transplant. 2021 Apr 20;26:e930243. doi: 10.12659/AOT.930243.
PubMed 33875633
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07423936
- Acronym / sponsor ID
- NONOFLOW / H24-00788
- Conditions
- Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
- Keywords
- Normothermic regional perfusion, donation after cardiac death, organ donation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consented Organ Donors | – | Other: NeuromonitoringConsented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consented eligible organ donors
Key inclusion criteria (2 listed)
- Age > 18;
- Planned DCD within the next 96 hours.
Key exclusion criteria (2 listed)
- Coagulopathy (International normalized ratio > 1.5, prothrombin time > 45 seconds, platelets < 50);
- Therapeutic anticoagulant medication administration.
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 |
|---|---|---|
| NeuromonitoringNeuromonitoring 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) | Other | Consented Organ Donors |
Primary outcome
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).
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.
1 secondary outcome
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
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 20 Feb 2026.
- Background: PubMed 36175093Murphy N, Lingard L, Blackstock L, Ott M, Slessarev M, Basmaji J, Brahmania M, Healey A, Shemie S, Skaro A, Wilson L, Weijer C. Protocol for a qualitative pilot study to explore ethical issues and stakeholder trust in the use of normothermic regional perfusion in organ donation in Canada. BMJ Open. 2022 Sep 29;12(9):e067515. doi: 10.1136/bmjopen-2022-067515.
- Background: PubMed 37131028Murphy NB, Weijer C, Slessarev M, Chandler JA, Gofton T. Implications of the updated Canadian Death Determination Guidelines for organ donation interventions that restore circulation after determination of death by circulatory criteria. Can J Anaesth. 2023 Apr;70(4):591-595. doi: 10.1007/s12630-023-02413-6. Epub 2023 May 2. No abstract available.
- Background: PubMed 37131020Shemie SD, Wilson LC, Hornby L, Basmaji J, Baker AJ, Bensimon CM, Chandler JA, Chasse M, Dawson R, Dhanani S, Mooney OT, Sarti AJ, Simpson C, Teitelbaum J, Torrance S, Boyd JG, Brennan J, Brewster H, Carignan R, Dawe KJ, Doig CJ, Elliott-Pohl K, Gofton TE, Hartwick M, Healey A, Honarmand K, Hornby K, Isac G, Kanji A, Kawchuk J, Klowak JA, Kramer AH, Kromm J, LeBlanc AE, Lee-Ameduri K, Lee LA, Leeies M, Lewis A, Manara A, Matheson S, McKinnon NKA, Murphy N, Briard JN, Pope TM, Sekhon MS, Shanker JJS, Singh G, Singh J, Slessarev M, Soliman K, Sutherland S, Weiss MJ, Shaul RZ, Zuckier LS, Zorko DJ, Rochwerg B. A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: a 2023 clinical practice guideline. Can J Anaesth. 2023 Apr;70(4):483-557. doi: 10.1007/s12630-023-02431-4. Epub 2023 May 2.
- Background: PubMed 30667536Shapey IM, Summers A, Augustine T, van Dellen D. Systematic review to assess the possibility of return of cerebral and cardiac activity after normothermic regional perfusion for donors after circulatory death. Br J Surg. 2019 Feb;106(3):174-180. doi: 10.1002/bjs.11046. Epub 2019 Jan 22.
- Background: PubMed 36227032Peled H, Mathews S, Rhodes D, Bernat JL. Normothermic Regional Perfusion Requires Careful Ethical Analysis Before Adoption Into Donation After Circulatory Determination of Death. Crit Care Med. 2022 Nov 1;50(11):1644-1648. doi: 10.1097/CCM.0000000000005632. Epub 2022 Oct 13. No abstract available.
- Background: PubMed 31922653Manara A, Shemie SD, Large S, Healey A, Baker A, Badiwala M, Berman M, Butler AJ, Chaudhury P, Dark J, Forsythe J, Freed DH, Gardiner D, Harvey D, Hornby L, MacLean J, Messer S, Oniscu GC, Simpson C, Teitelbaum J, Torrance S, Wilson LC, Watson CJE. Maintaining the permanence principle for death during in situ normothermic regional perfusion for donation after circulatory death organ recovery: A United Kingdom and Canadian proposal. Am J Transplant. 2020 Aug;20(8):2017-2025. doi: 10.1111/ajt.15775. Epub 2020 Jan 27.
- Background: PubMed 32541563van de Leemkolk FEM, Schurink IJ, Dekkers OM, Oniscu GC, Alwayn IPJ, Ploeg RJ, de Jonge J, Huurman VAL. Abdominal Normothermic Regional Perfusion in Donation After Circulatory Death: A Systematic Review and Critical Appraisal. Transplantation. 2020 Sep;104(9):1776-1791. doi: 10.1097/TP.0000000000003345.
- Background: PubMed 24136827Shapey IM, Muiesan P. Regional perfusion by extracorporeal membrane oxygenation of abdominal organs from donors after circulatory death: a systematic review. Liver Transpl. 2013 Dec;19(12):1292-303. doi: 10.1002/lt.23771.
- Background: PubMed 34856070Hessheimer AJ, de la Rosa G, Gastaca M, Ruiz P, Otero A, Gomez M, Alconchel F, Ramirez P, Bosca A, Lopez-Andujar R, Atutxa L, Royo-Villanova M, Sanchez B, Santoyo J, Marin LM, Gomez-Bravo MA, Mosteiro F, Villegas Herrera MT, Villar Del Moral J, Gonzalez-Abos C, Vidal B, Lopez-Dominguez J, Llado L, Roldan J, Justo I, Jimenez C, Lopez-Monclus J, Sanchez-Turrion V, Rodriguez-Laiz G, Velasco Sanchez E, Lopez-Baena JA, Caralt M, Charco R, Tome S, Varo E, Marti-Cruchaga P, Rotellar F, Varona MA, Barrera M, Rodriguez-Sanjuan JC, Briceno J, Lopez D, Blanco G, Nuno J, Pacheco D, Coll E, Dominguez-Gil B, Fondevila C. Abdominal normothermic regional perfusion in controlled donation after circulatory determination of death liver transplantation: Outcomes and risk factors for graft loss. Am J Transplant. 2022 Apr;22(4):1169-1181. doi: 10.1111/ajt.16899. Epub 2021 Dec 21.
- Background: PubMed 34729491Basmaji J, Weijer C, Skaro A, Healey A, Shemie SD, Slessarev M. Paving the Road for the Adoption of Normothermic Regional Perfusion in Canada. Crit Care Explor. 2021 Oct 28;3(11):e0553. doi: 10.1097/CCE.0000000000000553. eCollection 2021 Nov.
- Background: PubMed 33977568Ivanics T, Shwaartz C, Claasen MPAW, Patel MS, Yoon P, Raschzok N, Wallace D, Muaddi H, Murillo Perez CF, Hansen BE, Selzner N, Sapisochin G. Trends in indications and outcomes of liver transplantation in Canada: A multicenter retrospective study. Transpl Int. 2021 Aug;34(8):1444-1454. doi: 10.1111/tri.13903. Epub 2021 Jul 7.
- Background: PubMed 31193600Schaapherder A, Wijermars LGM, de Vries DK, de Vries APJ, Bemelman FJ, van de Wetering J, van Zuilen AD, Christiaans MHL, Hilbrands LH, Baas MC, Nurmohamed AS, Berger SP, Alwayn IP, Bastiaannet E, Lindeman JHN. Equivalent Long-term Transplantation Outcomes for Kidneys Donated After Brain Death and Cardiac Death: Conclusions From a Nationwide Evaluation. EClinicalMedicine. 2018 Oct 9;4-5:25-31. doi: 10.1016/j.eclinm.2018.09.007. eCollection 2018 Oct-Nov.
- Summary statistics on organ transplants, wait-lists and donors. 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Preservation and Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion, run by University of British Columbia at 1 site 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 2 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rebecca Grey Clinical Research Coordinator (604-875-4111 ext. 68336, cerebri.research@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423936, which also lists 16 linked publications.
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 20 Feb 2026.