Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Universal definition of perioperative bleeding in adult cardiac surgery
研究概览
简要总结
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.
Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
- •Referred for medically indicated aortic valve replacement
- •Sinus rhythm
- •Provide written informed consent
排除标准
- •Inclusion in other trial
- •Left ventricular ejection fraction less than 0.45
- •Presence of any coexisting severe valvular disorder
- •Previous cardiac surgery
- •Urgent or emergent surgery
结局指标
主要结局
Universal definition of perioperative bleeding in adult cardiac surgery
时间窗: Within 3 days from surgery
次要结局
未报告次要终点
研究者
Magnus Dalén
MD, PhD
Karolinska University Hospital
