Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After Death Determination by Circulatory Criteria

What this Trial Is About

Researchers are evaluating the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) for organ donors declared dead by circulatory criteria (DCC). The study aims to confirm that brain blood flow and activity do not resume during the A-NRP procedure by using a multimodal neuromonitoring protocol. This evidence will help ensure donor safety and support the use of A-NRP in standard organ donation practice. The study is a multi-center prospective observational cohort involving eligible DCC donors at participating hospitals. The A-NRP process will be implemented for organ recovery, with neuromonitoring performed by specialized teams independent of the transplant teams. Monitoring includes Transcranial colour-coded Doppler (TCCD) for brain blood flow, Electroencephalography (EEG) for cortical activity, and Somatosensory or brainstem auditory evoked potentials (SSEP or BAEP) for brainstem activity. These measures will be continuously recorded from before life support withdrawal through the A-NRP perfusion process. Participants will have multimodal neuromonitors placed prior to withdrawal of life support, and monitoring data will be collected during withdrawal and A-NRP. Researchers will interpret signals in real-time to detect any evidence of resumed brain blood flow or activity. The primary outcome is to confirm permanent cessation of brain circulation and activity. The study will also track donor accrual and consent rates, neuromonitoring performance, and signal duration over approximately one year of follow-up.

Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant