An observational study in Organ Preservation and Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by University of British Columbia · Observational
The aim of this study is to demonstrate that cerebral blood flow and brain function do not resume after death declaration in organ donors who undergo normothermic regional perfusion to restore organ function following death determination by circulatory criteria, when appropriate safeguards are applied.
To assess the absence of cerebral perfusion and function, investigators will use continuous and comprehensive multimodal neuromonitoring throughout the withdrawal of life-sustaining therapies, the dying process and the NRP procedure.
This will be a proof-of-concept study aimed at establishing the feasibility of multimodal neuromonitoring in patient undergoing abdominal (A-NRP) and thoraco-abdominal (TA-NRP) and to investigate whether resumption of CBF or function occurs in a cohort of DCD organ donors during A-NRP and TA-NRP. A central goal of this study is to demonstrate the absence of cerebral blood flow and function following normothermic regional perfusion, thereby improving clinical confidence to its safety and maintenance of adherence to death determination in organ donors.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consented eligible organ donors
Exclusion Criteria:
Consented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours.
Other: Neuromonitoring
Neuromonitoring during withdrawal of life sustaining therapies, dying process and during normothermic regional perfusion after death. The neuromonitoring will include: * Invasive intracranial pressure monitoring (Codman) * Bilateral invasive oxygentation monitoring (Licox) * Bilateral invasive blood flow monitoring (Hemedex) * Bilateral invasive EEG monitoring (Nantus) * Cerebral microdialysis * Transcranial doppler (Novosignal) * Jugular bulb oximetry (Edwards) * Surface EEG (Nantus) * Near infrared spectroscopy (Masimo) * Somatosensory and brainstem evoked potentials * Bispectral index (Masimo)
Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function)
To determine the presence or absence of the brain circulation and function during normothermic regional perfusion assessed by intra-parenchymal neuromonitoring, non-invasive neuromonitoring and clinical examination. Reperfusion or regain of brain function during normothermic regional perfusion will be expressed in proportion. Restoration of either cerebral perfusion or neurological function in a patient will be considered a single brain reanimation event. Clinical examination will consist of serial pupillary light reflex assessment and monitoring for respiratory efforts during normothermic regional perfusion. Evidence of brain function will be determined by the presence of rhythmic delta wave activity on electroencephalography, N20 response with somatosensory evoked potentials or presence of brainstem auditory evoked potentials. Restoration of brain circulation will be determined by the presence of cerebral blood flow (\>10mls/100g/min) or brain tissue oxygen tension (\>2mmHg).
Time frame: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
Aim 2: Feasibility of conducting multimodal monitoring
To assess the feasibility of implementing multimodal neuromonitoring in DCD organ donors undergoing normothermic regional perfusion. This will be a descriptive outcome in which investigators will calculate the duration of available data for each modality and compare it with the total observation period. The investigators hypothesized that feasibility will be strong and that \> 80% data variables will be collected for the pre-specified duration in each case.
Time frame: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
Aim 3: To assess the agreement between invasive and non-invasive neuromonitoring in determining the presence or absence of brain reanimation during normothermic regional perfusion.
To assess the agreement between invasive (intra-parenchymal cerebral blood flow, intra-parenchymal brain oxygenation, invasive EEG) and non invasive neuromonitoring (transcranial doppler, surface EEG, brainstem auditory evoked potentials, somatosensory evoked potentials) in determining the presence of brain circulation and function during normothermic regional perfusion
Time frame: During normothermic regional perfusion
Plan to share: Undecided
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University of British Columbia