Intraoperative Cell Salvage and Retrograde Autologous Priming in Patients Undergoing Isolated Coronary Bypass Grafting and Conventional Aortic Valve Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- number of red blood cell concentrates
研究概览
简要总结
In recent years Patient Blood Management (PBM) has developed into a multifactorial and interdisciplinary concept that focuses on individualized and optimized hemotherapy. Of course, this also applies to the cardiac surgery area (1). In this context, the quality of the intraoperative PBM can be represented by patients scheduled for isolated coronary artery bypass grafting (CABG) and isolated aortic valve replacement (AVR). In a prospective, observational "before-and-after" protocol, the investigators analysed the impact of the combined use of retrograde autologous priming (RAP) and cell salvage on intraoperative usage of red blood cell concentrates (RBC) (2).
详细描述
200 patients (CABG or AVR) will be monitored using local standard of care in these patients without cell salvage and RAP (control group, CG), followed by 200 patients with cell salvage and RAP (study group, SG). Both groups are defined by elective surgery and hemodynamically stable patients prior to the onset of the cardiopulmonary bypass (CPB). Based on our own data and current data from the literature, the investigators assume that the use of MAT in combination with RAP leads to at least an intraoperative reduction of the erythrocyte consumption of 15%. Consequently, the investigators calculated a case number of approximately 200 patients per group.
The study is set up with a control group under previous standard therapy. The data is recorded and analyzed descriptively. Qualitative comparisons will be made in the discussion of previously published data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •scheduled for cardiac surgery
- •informed written consent
排除标准
- •rejection by the patient
- •switching to another procedure
结局指标
主要结局
number of red blood cell concentrates
时间窗: through study completion, an average of 1 year
use of RBC
次要结局
- postoperative complications(through study completion, an average of 1 year)
- length of stay in hospital(through study completion, an average of 1 year)
- hospital mortality(through study completion, an average of 1 year)
研究者
Dr. Jochen Renner
Prof. Dr. med. Jochen Renner
University Hospital Schleswig-Holstein