Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Donor resumption of brain blood flow and/or activity
Study Overview
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:
- Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,
- Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Neuromonitoring (Other)
Outcomes
Primary Outcomes
Donor resumption of brain blood flow and/or activity
Time Frame: 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 Outcomes
- Neuromonitoring modalities(Through study completion, an average of 1 year)
- Neuromonitoring failure(Through study completion, an average of 1 year)
- Donor accrual rate(Through study completion, an average of 1 year)
- Consent rate(Through study completion, an average of 1 year)
- Duration and proportion of neuromonitoring signal(Through study completion, an average of 1 year)
Investigators
Anton Skaro
Director of Liver Transplantation Surgery and Associate Professor - Department of Surgery
Western University, Canada