跳至主要内容
临床试验/NCT01083914
NCT01083914已完成不适用

Investigation of the Ability of the MECC System to Provide Reduced Risk Over the Existing CECC System and Equivalent Risk to Off-Pump CABG Surgery: The IMPROVE TRIAL

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery.

研究概览

简要总结

The purpose of this study is to compare blood loss and the number of transfusions received by each patient having coronary bypass surgery. The second purpose is to determine how the level inflammation in patients during and after surgery may affect a patient's response to surgery and the recovery process.

详细描述

Off-pump coronary artery bypass grafting (OPCAB) and the use of minimal extracorporeal circulation system (MECC) have both been proposed as alternatives to avoid the harmful effects of conventional cardiopulmonary bypass (CPB). However, with the technically more demanding nature of off-pump CABG, the potential short-term benefits of off-pump surgery may not translate into long-term benefits in providing optimal revascularization. In this prospective cohort study, it is our goal to evaluate short term outcomes as demonstrated by blood loss, transfusion need, and systemic inflammatory response during CABG surgery using MECC or conventional CPB or OPCAB.

In addition to the technical challenges posed during off-pump CABG surgery, it is also known that a significant systemic inflammatory response is mounted in patients who undergo conventional CPB. This inflammatory response is a combined effect of 1) the placement of required tubes and lines for connection with the heart/lung machine, 2) hemodilution, and 3) hypothermia. In this study, we will measure levels of tissue inflammation through the use of specialized laboratory tests (C Reactive Protein, C5 complement activation and Interleukin 6), and we will correlate these inflammation levels to the three different cardiopulmonary bypass options. It is our hypothesis that MECC will provide the stable operating environment of conventional CPB and the patient benefits of less blood loss, decreased transfusion rate, and decreased inflammation levels seen in patients with OPCAB.

Statistical Analysis

Multivariable regression models will be used to investigate the association of the MECC pump, conventional CPB versus off-pump with the outcomes controlling for risk factors recognized by the STS associated with post-CABG adverse outcomes) and other clinical and non-clinical factors. The association of each outcome of interest with MECC versus conventional CPB and MECC versus off-pump will be estimated with 95% confidence intervals (CIs). With a cohort of 102 patients (34 in each of three study groups) we will have over 80% power to detect a 71% relative reduction (30% absolute difference) in transfusion rate among CABG patients using a MECC pump as compared to conventional pump patients assuming that 42% of patients undergoing CABG with conventional pump require a transfusion

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females at least 18 years of age undergoing CABG surgery who are suitable candidates cardiopulmonary bypass.

排除标准

  • Candidate requires emergency surgery.
  • Previous cardiac surgery.
  • Plans for concomitant cardiac valve surgery. (Note: concomitant vein isolation is permissible).
  • Pregnant or intends to become pregnant during the study.
  • Candidate is unable or unwilling to provide informed consent participate in the study.

结局指标

主要结局

To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery.

时间窗: 12 months

次要结局

  • To assess survival and readmission rates 30 days post discharge.(1 year)
  • To assess and compare levels of tissue inflammation using genomic mapping.(1 year)
  • To assess and compare levels of tissue inflammation using biomarkers.(1 year)
  • To identify a definition of a genomic signature of inflammation that predicts best outcomes in using CECC, MECC, and off-pump for CABG surgery.(1 year)
  • To use results of the trial to develop a a future large scale trial.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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