Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 570
- 试验地点
- 20
- 主要终点
- Perioperative bleeding
研究概览
简要总结
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device.
Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.
详细描述
The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected.
The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as:
- •Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s))
- •Primary or redo ascending aorta surgery
- •Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery
- •Free, informed and written consent signed by the participant and the investigator
排除标准
- •Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor)
- •Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis
- •Malignant tumor
- •Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS)
- •Emergency cardiac surgery
- •Heart transplantation
- •Implantation or patients under ventricular assist device (VAD)
- •Patients with two or more previous sternotomy
- •Surgery procedure requiring circulatory arrest and/or profound hypothermia (<32°C)
- •Active infective endocarditis
- •Cardiac surgical procedure for benign or malignant cardiac tumors
- •Patients with known acquired or constitutional coagulopathy requiring specialist management
- •End stage renal disease
- •Preoperative haemoglobin level less than 10 g/dL
- •Preoperative platelet count < 100 G/L
- •Persons participating in another interventional research including a period of exclusion that is still ongoing
- •Pregnant or breastfeeding women
- •Persons placed under judicial protection
- •Patients deprived of liberty
研究组 & 干预措施
Autotransfusion by filtration
new filtration-based autotransfusion (SAME I-SEP device)
干预措施: Autotransfusion (Procedure)
Autotransfusion by centrifugation
centrifugation-based autotransfusion (routinely used in cardiac surgery centers)
干预措施: Autotransfusion (Procedure)
结局指标
主要结局
Perioperative bleeding
时间窗: At the end of Day 1
The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding.
次要结局
- surgical re-exploration(Day 0-Day 5,)
- Sternal closure(Hours 12)
- Overall quality of perioperative haemostasis : Use of blood(Day 0-Day 2,)
- Perioperative biological hemostasis(Pre-inclusion - Day 5)
- ICU and hospital length of stay(End of study or early termination- Day 30)
- Early postoperative morbidity within 30 postoperative days(Day 30)
- total blood loss(Hours 12, Hours 24, up to 5 after operatives days)
- Complete blood count(Pre-inclusion - Day 5)