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

Organ Transplant Clinical Trial

Official title: Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities:

1. Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,

2. Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and

3. Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity.

The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario. ;

Related Conditions & MeSH terms

• Organ Transplant

• NCT number: NCT05884736
• Study type: Observational
• Source: Western University, Canada
• Contact: Crystal Engelage, PhD
• Phone: 519-685-8500
• Email: Crystal.Engelage@lhsc.on.ca
• Status: Recruiting
• Start date: April 2, 2024
• Completion date: December 2025