Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery: A Randomized Controlled Bi-Center Equivalence Trial
试验速览
- 阶段
- 不适用
- 发起方
- 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 surgeries that carry a major hemorrhagic risk 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 status after these types of surgeries, especially liver transplantation.
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 re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
详细描述
- Study design: Randomized controlled bi-center trial
- Primary objective: to compare platelet number and function after processing and re-transfusion of the salvaged blood to the patient by using different cell saver devices.
- Secondary (main) objectives: to compare a) the coagulation profile and b) the usage of blood products (frequency of administration of labile and stable blood products).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •All adult patients undergoing liver transplantation surgery
排除标准
- •Age < 18 years old
- •Active liver malignancy
- •Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
- •Inability to understand and sign the informed consent form
研究组 & 干预措施
SAME™ Device group
SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs
干预措施: Cell Salvage Autotransfusion: SAME™ device (Device)
Autolog™ Device group
Autolog™ standard autotransfusion device currently used at our institution
干预措施: Cell Salvage Autotransfusion: Autolog™ device (Device)
结局指标
主要结局
Platelet number
时间窗: Day 1
Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.
次要结局
- Blood hemoglobin level(Day 1)
- Platelet function(Day 1)
- Blood lactate level(Day 1)
- Blood plasma albumin level(Day 1)
- Free hemoglobin level(Day 1)
- Number of allogeneic blood products used(Day 1)
- Anti-Xa activity(Day 1)
- Amount of autologous blood at the end of the liver transplantation(Day 1)
- Number of coagulation concentrates used(Day 1)
研究者
Eduardo Schiffer
Professor, Head of Unit
University Hospital, Geneva