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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)
London Health Sciences Centre
London, Ontario, Canada
RECRUITINGToronto Western Hospital
Toronto, Ontario, Canada
NOT_YET_RECRUITINGDonor resumption of brain blood flow and/or activity
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
Time frame: Through study completion, an average of 1 year
Donor accrual rate
Number of eligible donors who are enrolled in the study and complete study procedures
Time frame: Through study completion, an average of 1 year
Consent rate
Number of donors who consent to study procedures divided by the number of donors approached for study consent (target ≥ 80%)
Time frame: Through study completion, an average of 1 year
Neuromonitoring modalities
Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities
Time frame: Through study completion, an average of 1 year
Duration and proportion of neuromonitoring signal
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)
Time frame: Through study completion, an average of 1 year
Neuromonitoring failure
Proportion of enrolled patients who had failure of neuromonitoring equipment during recording
Time frame: Through study completion, an average of 1 year
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