Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Platelet number
研究概览
简要总结
Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery.
There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population.
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Age >18 years
- •Elective high risk cardiac surgery with cardiopulmonary bypass usage
- •Cardiopulmonary bypass time > 120 minutes
- •Written informed consent
排除标准
- •Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
- •Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
研究组 & 干预措施
Patients undergoing cardiac surgery using the cell saver device
干预措施: Autologous cell salvage with i-Sep SAME device (Device)
Patients undergoing cardiac surgery using the conventional cell saver device
干预措施: Autologous blood cell salvage with in-house device (Device)
结局指标
主要结局
Platelet number
时间窗: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.
次要结局
- Platelet function measured by multiple electrode aggregometry(Perioperative period (begins on the day of surgery and ends on the day after surgery))
- Platelet function measured by platelet activation markers (GPIb and GPIIb)(Perioperative period (begins on the day of surgery and ends on the day after surgery))
- Platelet function measured by platelet activation markers (P-selectin)(Perioperative period (begins on the day of surgery and ends on the day after surgery))
- Number of allogeneic blood products transfused(Perioperative period (begins on the day of surgery and ends on the day after surgery))
- Platelet function measured with viscoelastic point-of-care test (Clotpro)(Perioperative period (begins on the day of surgery and ends on the day after surgery))
- Platelet function measured with viscoelastic point-of-care test (ROTEM)(Perioperative period (begins on the day of surgery and ends on the day after surgery))