跳至主要内容
临床试验/NCT00123981
NCT00123981已完成不适用

The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)

Kim Houlind2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900
试验地点
2
主要终点
A combined endpoint of death + stroke + myocardial infarction within 30 days from operation

研究概览

简要总结

Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.

The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.

详细描述

Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.

During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.

Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.

The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.

Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age seventy years or above
  • Admitted for first time coronary artery bypass operation

排除标准

  • Given information cannot be understood
  • Aortic crossclamping not safe due to calcification
  • Preoperative cardiac conditions demanding cardiopulmonary bypass
  • Re-do cardiac surgery
  • Patients requiring operation within the same day after conference

结局指标

主要结局

A combined endpoint of death + stroke + myocardial infarction within 30 days from operation

时间窗: 30 days

次要结局

  • A combined endpoint of death + stroke + myocardial infarction during follow-up(3 years)
  • Patency of bypass grafts assessed by coronary angiography 6 months after the operation(6 months)
  • Total mortality and cardiac mortality during follow-up(3 years)
  • Need of new intervention for cardiac angina during follow-up(3 years)
  • Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation(6 months and 3 years)
  • Total hospital costs and costs of public care provided 6 months and 3 years after the operation and difference in costs per quality adjusted life year(6 months and 3 years)

研究者

发起方
Kim Houlind
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kim Houlind

Senior consultant, Associate Professor

Odense University Hospital

研究点 (2)

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