NCT01253356终止4 期
A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction < or = 30%)
排除标准
- •Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score > or = 5 Pregnancy Inability to provide informed consent
研究组 & 干预措施
No IABP
No Intervention
Standard of care and no IABP
Intra-Aortic Balloon Pump (IABP)
Active Comparator
Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery
干预措施: IABP (Device)
结局指标
主要结局
Safety
时间窗: 30 days
Amputation, Clinically significant bleeding, Vascular complications
次要结局
- Efficacy(30 days)
研究者
研究点 (1)
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