急性缺血性卒中机械取栓期间经脾脏远程低温治疗安全性和神经保护疗效的前瞻性随机对照试验：原理、设计与方案
Prospective randomized controlled trial on the safety and neuroprotective efficacy of remote administration of hypothermia over spleen during acute ischemic stroke with mechanical thrombectomy: rationale, design, and protocol.
作者信息
Duan Honglian, Cheng Zhe, Geng Xiaokun, Rajah Gary B, Gao Jie, Guo Yang, Cai Lipeng, Tong Yanna, Li Fengwu, Jiang Qian, Han Zhenzhen, Ding Yuchuan
机构信息
Department of Neurology and Stroke Center, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
Luhe Institute of Neuroscience, Capital Medical University, Beijing, China.
出版信息
Front Neurol. 2024 Jul 16;15:1382365. doi: 10.3389/fneur.2024.1382365. eCollection 2024.
BACKGROUND
Brain inflammation plays a key role in ischemia/reperfusion (I/R) injury and is the main cause of "ineffective or futile recanalization" after successful mechanical thrombectomy (MT) in acute ischemic stroke (AIS). One of the primary sources of inflammatory cells after AIS are derived from the spleen. As an innovative and potential neuroprotective strategy after stroke, Remote Administration of Hypothermia (RAH) temporarily suppresses immune activities in the spleen, reduces the release of inflammatory cells and cytokines into blood, and thus reversibly diminishes inflammatory injury in the brain.
METHODS
This single-center, prospective, randomized controlled study (RCT) is proposed for AIS patients with anterior circulation large vessel occlusion (LVO). Subjects will be randomly assigned to either the control or intervention groups in a 1:1 ratio ( = 40). Participants allocated to the intervention group will receive RAH on the abdomen above the spleen prior to recanalization until 6 h after thrombectomy. All enrolled patients will receive standard stroke Guideline care. The main adverse events associated with RAH are focal cold intolerance and abdominal pain. The primary outcome will assess safety as it pertains to RAH application. The secondary outcomes include the efficacy of RAH on spleen, determined by spleen volumes, blood inflammatory factor (cells and cytokines), and on brain injury, determined by infarction volumes and poststroke functional outcomes.
DISCUSSION
This study aims to examine the safety and preliminary effectiveness of RAH over the spleen during endovascular therapy in AIS patients. The results of this study are expected to facilitate larger randomized clinical trials and hopefully prove RAH administration confers adjuvant neuroprotective properties in AIS treated with MT.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn/. Identifier ChiCTR 2300077052.
背景
脑炎症在缺血/再灌注（I/R）损伤中起关键作用，是急性缺血性卒中（AIS）患者成功进行机械取栓术（MT）后出现“无效或徒劳再通”的主要原因。AIS后炎症细胞的主要来源之一是脾脏。作为一种创新且具有潜在神经保护作用的卒中后策略，远程低温治疗（RAH）可暂时抑制脾脏的免疫活动，减少炎症细胞和细胞因子释放入血，从而可逆性减轻脑内的炎症损伤。
方法
本单中心、前瞻性、随机对照研究（RCT）拟纳入前循环大血管闭塞（LVO）的AIS患者。受试者将按1:1比例随机分为对照组或干预组（每组n = 40）。分配至干预组的参与者将在再通前在脾脏上方的腹部接受RAH治疗，直至取栓术后6小时。所有入组患者均接受标准的卒中指南治疗。与RAH相关的主要不良事件是局部冷不耐受和腹痛。主要结局将评估与RAH应用相关的安全性。次要结局包括通过脾脏体积、血液炎症因子（细胞和细胞因子）评估RAH对脾脏的疗效，以及通过梗死体积和卒中后功能结局评估RAH对脑损伤的疗效。
讨论
本研究旨在探讨AIS患者血管内治疗期间对脾脏进行RAH的安全性和初步有效性。本研究结果有望推动更大规模的随机临床试验，并有望证明在接受MT治疗的AIS患者中，给予RAH具有辅助神经保护作用。
临床试验注册
https://www.chictr.org.cn/。标识符：ChiCTR 2300077052。
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