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Recruiting NCT07423936

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

— Observational Organ Preservation Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuromonitoring.
Who it may be relevant to
Registry conditions: Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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 i

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (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. [Time frame: During normothermic regional perfusion]

Eligibility criteria

Inclusion criteria

  • Age > 18;
  • Planned DCD within the next 96 hours.

Exclusion criteria

  • Coagulopathy (International normalized ratio > 1.5, prothrombin time > 45 seconds, platelets < 50);
  • Therapeutic anticoagulant medication administration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Vancouver General Hospital — Vancouver

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. PMID 36175093
  • Murphy 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. PMID 37131028
  • Shemie 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, Leei PMID 37131020
  • Shapey 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. PMID 30667536
  • Peled 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. PMID 36227032
  • Manara 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 Un PMID 31922653
  • van 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. PMID 32541563
  • Shapey 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. PMID 24136827

Identifiers

NCT: NCT07423936 · H24-00788

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗