Recruiting

DCC Organ Transplant

Sponsor:

Western University, Canada

Code:

NCT05884736

Conditions

Organ Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuromonitoring

Study Details

Brief 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. 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.

Conditions

Organ Transplant

Study ID

NCT05884736

Start date

Apr 2, 2024

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≤ 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.

Exclusion Criteria:

  • < 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Neuromonitoring

Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)

Primary outcome measure

  • Donor resumption of brain blood flow and/or activity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Crystal Engelage, PhD

519-685-8500Crystal.Engelage@lhsc.on.ca

Anton Skaro, MD PhD

519-663-2904Anton.Skaro@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Crystal Engelage, PhD

519-685-8500Crystal.Engelage@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • A-NRP
  • neuromonitoring
  • brain activity
  • transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2026-05-19.