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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Other 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 measures

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

Secondary outcome measures (5)

• Donor accrual rate [Time frame: Through study completion, an average of 1 year]
• Consent rate [Time frame: Through study completion, an average of 1 year]
• Neuromonitoring modalities [Time frame: Through study completion, an average of 1 year]
• Duration and proportion of neuromonitoring signal [Time frame: Through study completion, an average of 1 year]
• Neuromonitoring failure [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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

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 · 2 centers

• London Health Sciences Centre — London
• Toronto Western Hospital — Toronto

Identifiers

NCT: NCT05884736 · 4436

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗