Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures.

In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessation of brain activity and circulatory arrest during the dying process threatens public and healthcare provider trust in deceased organ donation. In this cohort study, we will prospectively record cerebral and brainstem electrical activity, cerebral blood flow velocity and arterial blood pressure using electroencephalography (EEG), brainstem evoked potentials, transcranial doppler and bedside haemodynamic monitors in adult patients undergoing planned withdrawal of life sustaining measures in the intensive care units at five hospital sites for 18 months. We will use MATLAB to synchronise waveform data and compute the time of cessation of each signal relative to circulatory arrest. Our primary outcome is the feasibility of patient accrual, while secondary outcomes are (a) proportion of patients with complete waveform recordings and data transfer to coordinating site and (b) time difference between cessation of neurophysiological signals and circulatory arrest. We expect to accrue 1 patient/site/month for a total of 90 patients. We have ethics approval from Clinical Trials Ontario (protocol #3862, version 1.0, date 19 January 2022.) and the relevant Research Ethics Board for each site. We will obtain written informed consent from legal substitute decision makers. We will present study results at research conferences including donor family partner forum and in peer-reviewed publications. NCT05306327.

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Déclaration de conflit d'intérêts

Competing interests: TG has received an honorarium from Novartis and research funding from the Academic Medical Organisation of Southwestern Ontario and Lawson Health Research Institute Internal Research Fund for unrelated research. SE is supported by a Heart and Stroke Foundation National New Investigator Award. FDA is supported by the Fond de recherche du Québec-Santé career Award. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. JGB, EC, JC, MC, NBS, Y-HC, TAF, AHK, JK, NBM, JS and MJS declare no competing interests. MS receives a stipend for his work as a Regional Medical Lead (Donation) with Ontario Health (Trillium Gift of Life Network).