NCT02682849已完成不适用
Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
John M. Stulak1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of interventions to Treat Retained Blood Syndrome
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
- •Patient undergoing cardiac surgery via sternotomy
排除标准
- •Robotic surgery
- •Any access via thoracotomy
- •Any condition deemed inappropriate for inclusion by the investigators.
- •Intolerance to implantable silicone materials.
结局指标
主要结局
Number of interventions to Treat Retained Blood Syndrome
时间窗: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days
Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.
次要结局
- Number of episodes of new on set of post operative atrial fibrillations (POAS)(30 day)
- Number of readmissions for any diagnosis of RBS or POAS re-occurrences(30 day)
研究者
John M. Stulak
Principal Investigator
Mayo Clinic
研究点 (1)
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