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临床试验/NCT00059319
NCT00059319已完成3 期

Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

National Institute of Neurological Disorders and Stroke (NINDS)2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 1999年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
2

研究概览

简要总结

The purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.

详细描述

Patients who have coronary artery bypass graft (CABG) surgery must have their aorta (the large blood vessel that is attached to the heart) clamped with an instrument. There are two basic ways of manipulating the aorta during surgery. One way is to place a single clamp across the aorta. The other way is to place more than one clamp on the aorta in several places. Both methods are used, but it is not known if one way is better than the other.

The purpose of this study is to compare the two methods of clamping to see if one way is better than the other, and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during CABG surgery and have a lower incidence of neurobehavioral problems following surgery. Microemboli are tiny fat particles that enter the bloodstream during surgery, circulate to the brain, and block tiny blood vessels, causing brain deficits.

Participants in this trial will be randomly classified into one of two groups: the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection, and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection. Neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

研究点 (2)

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