Organ Transplant
Conditions
Keywords
A-NRP, neuromonitoring, brain activity, transplant
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.
Interventions
OTHERNeuromonitoring
Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)
Sponsors
University Health Network, Toronto
Western University, Canada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor resumption of brain blood flow and/or activity | Through study completion, an average of 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Donor accrual rate | Through study completion, an average of 1 year | Number of eligible donors who are enrolled in the study and complete study procedures |
| Consent rate | Through study completion, an average of 1 year | Number of donors who consent to study procedures divided by the number of donors approached for study consent (target ≥ 80%) |
| Neuromonitoring modalities | Through study completion, an average of 1 year | Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities |
| Duration and proportion of neuromonitoring signal | Through study completion, an average of 1 year | Duration of continuous neuromonitoring and proportion of total recording time with adequate signal per patient (velocity waveforms for TCCD, uv/mm for EEG, brainstem auditory evoked potentials (BAEP) signal, and somatosensory evoked potentials (SSEP) signal) |
| Neuromonitoring failure | Through study completion, an average of 1 year | Proportion of enrolled patients who had failure of neuromonitoring equipment during recording |
Countries
Canada
Contacts
Primary ContactCrystal Engelage, PhD
Backup ContactAnton Skaro, MD PhD
Outcome results
None listed