Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE): trial protocol for a randomised controlled multicentre trial
Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE): trial protocol for a randomised controlled multicentre trial
复制标题
通过胸腹分期和“微创分期节段动脉线圈栓塞”（MIS²ACE）预防主动脉瘤修复中的截瘫：随机对照多中心试验的试验方案
作者：
D. Petroff;M. Czerny;T. Kölbel;G. Melissano;L. Lønn;J. Haunschild;K. von Aspern;P. Neuhaus;J. Pelz;D. Epstein;N. Romo;Katja Piotrowski;C. Etz
脊髓损伤（SCI）包括永久性截瘫是胸腹主动脉瘤修复后的常见并发症。分期修复的概念有望通过诱导动脉生成提供保护，使侧支网络可以在干预后为脊髓提供强大的血液供应。微创分段动脉弹簧圈栓塞术（MIS 2ACE）最近已被证明是一种可行的增强方法分期修复。方法和分析本随机对照试验采用多中心、多国、平行组设计，其中500例患者将以1：1的比例随机分配至标准动脉瘤修复术或MIS 2ACE，接受1-3次治疗，随后进行修复。在随机化之前，医生记录计划进行开放性或腔内修复术。主要终点是动脉瘤修复成功，动脉瘤修复后30天无严重SCI。次要终点包括任何形式的SCI、死亡率（最长1年）、重症监护室的住院时间、成本和质量调整生命年。将使用广义线性混合模型，logit链接函数和随机化组、修复方式（开放或腔内修复）、Crawford类型和欧洲心脏手术风险评价系统（euroSCORE）II作为固定效应，中心作为随机效应。安全性终点包括肾衰竭、呼吸衰竭和栓塞事件（也来自碎片）。定性研究将探讨患者的看法。本试验已获得莱比锡大学（435/17-ek）伦理委员会的批准，并将由试验中心的每个伦理委员会进行审查。一个专门的项目正在协调试验的沟通和传播。试验注册号NCT 03434314。
Introduction Spinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS2ACE) has been proved recently to be a feasible enhanced approach to staged repair. Methods and analysis This randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 1:1 ratio to standard aneurysm repair or to MIS2ACE in 1–3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1 year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions. Ethics and dissemination This trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial. Trial registration number NCT03434314.
影响因子：
6
作者：
Etz, Christian D.;Kari, Fabian A.;Mueller, Christoph S.;Brenner, Robert M.;Lin, Hung-Mo;Griepp, Randall B.
通讯作者：
Griepp, Randall B.
DOI：
10.1016/j.jtcvs.2007.11.002
发表时间：
2008-02-01
影响因子：
6
作者：
Etz, Christian D.;Luehr, Maximilian;Griepp, Randall B.
通讯作者：
Griepp, Randall B.