Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Platelet count
研究概览
简要总结
Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 over 18 years of age
- •Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
- •Treated with an autotransfusion device during the surgery
- •Subject having expressed their consent to the study
排除标准
- •Anemia less than 7 g/dL
- •Pregnant women
- •Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
- •Contraindication to the use of an autotransfusion device
- •Impossibility of giving the subject informed information
结局指标
主要结局
Platelet count
时间窗: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery
次要结局
- To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- To study the evolution of platelet function (flow cytometry and flow aggregation) following the use of a autotransfusion device in major patients undergoing standard cardiac surgery.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- Study the evolution of platelet function according to the autotransfusion device used.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- Study post-operative bleeding volume as a function of autotransfusion device type.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- Study the volume of labile blood product transfusion according to the autotransfusion device used.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)
- Study platelet adhesion to the autotransfusion device membranes using electron microscopy.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)