Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- To determine what is the best method of brain protection during long periods of circulatory arrest
研究概览
简要总结
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
详细描述
The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.
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
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing a total arch replacement
- •Less than 75 years old
排除标准
- •EF less than 35%
- •Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
- •Pt unable to complete preop neuro assessment
- •Pt is unwilling or able to complete followup requirements
- •Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
- •Pt is a female who is pregnant or lactating
- •Pt has history of stroke
研究组 & 干预措施
Retrograde brain perfusion
Pt may be randomized to retrograde brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine.
干预措施: Retrograde brain perfusion (Procedure)
Antegrade brain perfusion
Pt may be randomized to antegrade brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine.
干预措施: Antegrade brain perfusion (Procedure)
结局指标
主要结局
To determine what is the best method of brain protection during long periods of circulatory arrest
时间窗: 6 months
次要结局
- Will one method of brain protection be better than the other in prevention of post-op stroke and which method will provide freedom from postop neurobehavioural deficit at 6 months postop.(6 months)