ACTRN12614000712606终止2 期
High risk patients undergoing prophylactic intraaortic balloon counterpulsation compared with standard care without intraaortic balloon pump: A feasibility study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years(—)
- 性别
- All
入选标准
- •1.The patient is listed for cardiac surgery that includes CABG
- •2.The treating surgical team considers prophylactic IABC may be of benefit
- •Severely impaired left ventricular function of any cause
- •Recent or ongoing myocardial ischaemia+
- •Critical coronary artery stenosis
- •+myocardial ischaemia defined by pain at rest, requirement for IV GTN or heparin, or elevated troponin.
排除标准
- •1.Patient age <18 years
- •2.Patient has an IABC, ventricular assist device or ECMO circuit in situ
- •3.IABC placement is planned for an immediate therapeutic indication (e.g. cardiogenic shock, severe mitral regurgitation)
- •4.Absolute contraindication to IABC
- •a.Severe bilateral lower limb peripheral vascular disease or bilateral femoral arterial grafting
- •b.Moderate or severe aortic regurgitation
- •c.Abdominal or thoracic aortic aneurysm, severe calcification or dissection
- •d.Infection overlying bilateral femoral arteries
- •5.Treating clinician deems enrollment is not in the best interest of the patient
- •6.Death is imminent and inevitable
- •7.Weight <40kg
- •8.Patient is highly unlikely to be contactable at 6 months for follow up
研究者
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