Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Labile blood products measure
研究概览
简要总结
Transfusion in lung transplantation is common, and despite improved techniques and limitations in the use of mechanical circulatory support (MCS), the incidence of massive transfusion has remained stable over the years. The consequences of blood transfusion (blood cells, plasma, platelet concentrates) are deleterious for patients and increase primary graft dysfunction and mortality risk.
Whole blood viscoelastic testing devices have shown its effectiveness in monitoring coagulation and fibrinolytic function during cardiac surgery, liver transplantation or trauma. So far, few delocalized biology tools have been evaluated in lung transplantation.
The main objective of this study is to determine if the use of a transfusion algorithm based on whole blood viscoelastic test with Quantra® test reduce transfusion during lung transplantation.
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
- •Patients undergoing double-lung transplantation
- •Patient is ≥ 18 years-old
- •Patient is willing to participate, and is willing to consent
- •Patient affiliated to a national health insurance
排除标准
- •Patient is younger than 18 years-old
- •Patient with an indication for non double-lung transplantation
- •Patient under extracorporeal membrane oxygenation in bridge to transplantation
- •Patient with surgery under cardiopulmonary bypass
- •Patient benefiting from a multi-organ transplantation
- •Patient being deprived of liberty or under guardianship
- •Patient refusing to participate
研究组 & 干预措施
QUANTRA group
Adult subjects (18 years-old or older) undergoing double-lung transplantation: transfusion algorithm based on whole blood viscoelastic test with Quantra® + standard coagulation test. These samples are collected at five standard surgical time points:
- on arrival at the hospital on the day of surgery,
- after first pulmonary artery clamping,
- after first graft implantation,
- after second graft implantation,
- at end-surgery status.
干预措施: Quantra (Other)
Control group
Adult subjects (18 years-old or older) undergoing double-lung transplantation: standard transfusion algorithm based on standard practice and coagulation test. These samples are collected at five standard surgical time points:
- on arrival at the hospital on the day of surgery,
- after first pulmonary artery clamping,
- after first graft implantation,
- after second graft implantation,
- at end-surgery status.
干预措施: Control (Other)
结局指标
主要结局
Labile blood products measure
时间窗: 24 hours
Number of labile blood products (red blood cells pack + fresh frozen plasma) transfused in the operating room.
次要结局
- The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation(24 hours)
- blood loss during surgery(24 hours)
- Hospital mortality, at 30 days, 90 days, and 12 months(12 months)
- Duration of stay in intensive care(up to 12 months)
- Quality of life six months after surgery using EQ-5D-5L questionnaire including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression(6 months)
- Number of transfused labile blood products during the length of an individual's stay in hospital(up to 12 months)
- The median cost of transfused labile blood products(up to 12 months)
- The occurrence of acute primary graft dysfunction at day 3.(3 days)