Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant

NCT05884736 | Recruiting DMC

• 1 other identifier: 4436
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

A-NRP; neuromonitoring; brain activity; transplant

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Donor accrual rate

  Through study completion, an average of 1 year

• Consent rate

  Through study completion, an average of 1 year

• Neuromonitoring modalities

  Through study completion, an average of 1 year

• Duration and proportion of neuromonitoring signal

  Through study completion, an average of 1 year

• Neuromonitoring failure

  Through study completion, an average of 1 year

Study Arms (1)

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.

Other: Neuromonitoring

Interventions

Neuromonitoring OTHER

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

DCC Donors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≤ 18 years of age

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Western University, Canada: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

NOT YET RECRUITING

Study Officials

• Anton Skaro, MD PhD

  London Health Sciences Centre/Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Engelage, PhD

CONTACT

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

Anton Skaro, MD PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Transplantation Surgery and Associate Professor - Department of Surgery

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 1, 2023
• Study Start: April 2, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)