Krzysztof Szwed, Wojciech Pawliszak, Zbigniew Serafin, Mariusz Kowalewski, Remigiusz Tomczyk, Damian Perlinski, Magdalena Szwed, Marta Tomaszewska, Lech Anisimowicz, Alina Borkowska
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland.
Department of Cardiac Surgery, Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland.
BMJ Open. 2017 Jul 10;7(7):e016785. doi: 10.1136/bmjopen-2017-016785.
Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.
In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.
Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media.
NCT03074604; Pre-results.
10-Mar-2017 Original.
冠状动脉旁路移植术（CABG）后神经损伤仍是一个主要问题，抵消了CABG相对于经皮冠状动脉介入治疗的生存获益。为解决这一问题进行了诸多努力，其中包括非体外循环冠状动脉旁路移植术（OPCABG）的发展，该技术无需体外循环，且与改善神经结局相关。本研究的目的是探讨使用两种先进的手术技术是否能进一步增强OPCABG的神经保护作用。
在这项随机、对照、研究者和患者双盲的单中心优效性试验中，设有三个平行组，共将招募360例患者。他们将按1:1:1的比例分配到两个治疗组和一个对照组。将接受主动脉非接触式OPCABG或采用部分阻断并应用二氧化碳手术野灌注的OPCABG的治疗组与接受部分阻断OPCABG的对照组进行比较。主要终点将是术后3天对照脑MRI上新病变的出现。次要终点将包括术后前7天新的局灶性神经功能缺损的发生率、术后1周或3个月时术后认知功能障碍的发生情况以及术后前7天谵妄的发生率。数据将按照意向性分析原则和符合方案分析进行分析。
本研究已获得伦理批准。结果将通过同行评审媒体进行传播。
NCT03074604；预结果。
2017年3月10日 原始版本
