Multimodal NeurOmonitoring During NormOthermic Regional PerFusion for Organ Donors Determined Dead by CircuLatory Criteria fOllowing Withdrawal of Life Sustaining Measures (NONOFLOW): A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned DCD within the next 96 hours.
排除标准
- •Coagulopathy (International normalized ratio > 1.5, prothrombin time > 45 seconds, platelets < 50);
- •Therapeutic anticoagulant medication administration.
研究组 & 干预措施
Consented Organ Donors
Consented for organ donation following withdrawal of life-sustaining measures and planned DCD within the next 96 hours.
干预措施: Neuromonitoring (Other)
结局指标
主要结局
Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function)
时间窗: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
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).
Aim 2: Feasibility of conducting multimodal monitoring
时间窗: One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
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.
次要结局
- 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.(During normothermic regional perfusion)
研究者
Myp Sekhon
Principal investigator and clinical professor, MD, PhD
University of British Columbia