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MIECC vs Conventional Cardiopulmonary Bypass and Systemic Inflammation in CABG (MIECC-CABG)

2026年9月15日 更新者：Umran Karaca、Bursa Yuksek Ihtisas Training and Research Hospital

Comparison of the Effects of Minimally Invasive and Conventional Extracorporeal Circulation on Systemic Inflammation Indices in Coronary Artery Bypass Surgery

This prospective observational study evaluates the effects of minimally invasive extracorporeal circulation (MIECC) and conventional cardiopulmonary bypass on systemic inflammatory response in patients undergoing coronary artery bypass graft surgery. Adult patients undergoing elective coronary artery bypass surgery will be observed according to the extracorporeal circulation technique used during surgery. Systemic inflammation will be assessed using routinely available hematologic inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII). These parameters will be evaluated preoperatively, at postoperative 6 hours, at postoperative 24 hours, and at hospital discharge. The study will also evaluate selected perioperative and postoperative clinical outcomes in order to compare the inflammatory response associated with MIECC and conventional extracorporeal circulation.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Coronary artery bypass graft surgery performed with cardiopulmonary bypass is associated with activation of systemic inflammatory pathways. Contact of blood with the extracorporeal circuit, surgical trauma, ischemia-reperfusion injury, and perioperative factors may contribute to this response. Minimally invasive extracorporeal circulation systems are designed to reduce blood-air contact, circuit surface area, and hemodilution and may therefore attenuate the inflammatory response compared with conventional cardiopulmonary bypass.

In this prospective observational study, patients undergoing elective coronary artery bypass graft surgery will be evaluated according to whether minimally invasive extracorporeal circulation or conventional extracorporeal circulation is used during surgery. No treatment assignment will be made by the study protocol.

Inflammatory response will be assessed using neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammation index calculated from routinely obtained laboratory measurements. Measurements will be evaluated preoperatively, at 6 hours after surgery, at 24 hours after surgery, and at hospital discharge. Perioperative variables and postoperative clinical outcomes will also be recorded for comparison between the two groups.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Bursa
      • Bursa、Bursa、土耳其（türkiye）、16000
        • 招聘中
        • Bursa Yuksek Ihtisas Training and Research Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients aged 30-70 years undergoing elective coronary artery bypass graft surgery with either minimally invasive extracorporeal circulation or conventional cardiopulmonary bypass at Bursa Yuksek Ihtisas Training and Research Hospital.

描述

Inclusion Criteria:

  • Age 30-70 years
  • Patients undergoing elective coronary artery bypass graft surgery
  • Patients in whom cardiopulmonary bypass is planned
  • Written informed consent obtained

Exclusion Criteria:

  • Emergency surgery
  • Redo cardiac surgery
  • Concomitant valve surgery
  • Previous open heart surgery
  • Preoperative renal and/or hepatic failure
  • Malignancy
  • Active infection or inflammatory disease-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
MIECC Group
Patients undergoing coronary artery bypass graft surgery using minimally invasive extracorporeal circulation (MIECC) as part of routine clinical care.
程序：Minimally Invasive Extracorporeal Circulation
Use of a minimally invasive extracorporeal circulation system during coronary artery bypass graft surgery as part of routine clinical care.
Conventional Cardiopulmonary Bypass Group
Patients undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass as part of routine clinical care.
程序：Conventional Cardiopulmonary Bypass
Use of conventional cardiopulmonary bypass during coronary artery bypass graft surgery as part of routine clinical care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Neutrophil-to-Lymphocyte Ratio (NLR)
大体时间：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
NLR will be calculated from routine complete blood count values by dividing the absolute neutrophil count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
Platelet-to-Lymphocyte Ratio (PLR)
大体时间：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
PLR will be calculated from routine complete blood count values by dividing the platelet count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
Systemic Immune-Inflammation Index (SII)
大体时间：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
SII will be calculated as neutrophil count × platelet count / lymphocyte count using routine complete blood count values. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bursa Yuksek Ihtisas Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月7日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年9月10日

首先提交符合 QC 标准的

2026年9月15日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024-TBEK 2026/01-10

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent process.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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