Clinical trial NCT05884736: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Organ Transplant
Keywords: A-NRP
neuromonitoring
brain activity
transplant
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2023-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Donor resumption of brain blood flow and/or activity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Donor accrual rate
timeFrame: Through study completion, an average of 1 year
measure: Consent rate
timeFrame: Through study completion, an average of 1 year
measure: Neuromonitoring modalities
timeFrame: Through study completion, an average of 1 year
measure: Duration and proportion of neuromonitoring signal
timeFrame: Through study completion, an average of 1 year
measure: Neuromonitoring failure
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre/Lawson Health Research Institute
name: Anton Skaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: