Recruiting

Neuromonitoring Study

Sponsor:

University of British Columbia

Code:

NCT07423936

Conditions

Organ Preservation

Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Neuromonitoring

Study Details

Brief 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.

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.

Conditions

Organ Preservation

Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion

Study ID

NCT07423936

Start date

Feb 24, 2025

Status verified date

Feb, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Consented Organ Donors

Consented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours.

Interventions

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)

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Rebecca Grey Clinical Research Coordinator

604-875-4111cerebri.research@ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Mypinder Sekhon

604-875-5949myp@mail.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Feb 20, 2026

Last verified

Feb, 2025

Keywords

  • Normothermic regional perfusion
  • donation after cardiac death
  • organ donation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-02-20.