Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measurement of red blood cell numeration from blood collected.
研究概览
简要总结
The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.
The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.
The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.
Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.
There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.
The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age ≥ 18 years;
- •Any open heart surgery with or without extracorporeal circulation
- •Signature of informed consent
- •Affiliation to social security
排除标准
- •Subjects legally protected or unable to consent
- •Persons deprived of liberty
- •Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent)
- •Pregnant or breastfeeding women
结局指标
主要结局
Measurement of red blood cell numeration from blood collected.
时间窗: Between the incision and the closure.
次要结局
未报告次要终点
