Perioperative Hemostasis Management in Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 16
- 主要终点
- Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT
研究概览
简要总结
Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Diffuse bleeding can occur at any time during the 3 phases of surgery: dissection, anhepatic and neohepatic. However, intraoperative bleeding and transfusion requirements remain difficult to predict. Current predictive models are based in particular on preoperative characteristics and do not take into account the course and different phases of the operation.
The need for transfusions has largely decreased over the last 20 years, and currently around 20-25% of patients are transfused (transfusion of at least 1 blood product during LT). However, massive transfusion is necessary in 10% of LT. The European Society of Anaesthesiology (ESA) has issued recommendations on the management of severe bleeding during surgery. However, these recommendations are not specific to LT. Moreover, transfusion strategies vary widely from one center to another. The implementation of protocols within teams dedicated to LT has led to a reduction in bleeding and transfusion, with or without the use of viscoelastic testing.
Intraoperative bleeding and transfusion requirements, as well as postoperative thromboembolic complications, remain difficult to predict. Predictive models of bleeding risk have been developed, but they are based solely on preoperative characteristics and do not take into account the course and various phases of the operation. In addition, new methods such as Bayesian inference or machine learning have been developed, and seem capable of providing different information from that obtained by conventional models.
The overall aim of this prospective multicenter observational study is to investigate the risk factors for bleeding and thrombosis in per- and post-operative LT using different predictive methods, and to describe the management of bleeding and post-operative anticoagulation in metropolitan France.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 aged 18 or over
- •Liver transplant patient
排除标准
- •Multi-organ transplantation
- •Protected populations: under guardianship or curatorship
- •Patients not affiliated to a social security scheme
结局指标
主要结局
Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT
时间窗: number of pRBCs transfused during surgery
Number of intraoperative pRBCs transfused
次要结局
- Determine the predictive factors for intraoperative transfusion of RBCs for LT(During surgery)
- Determine the predictive factors of the number of RBCs transfused at each phase of LT(During surgery)
- Determine factors predicting intraoperative bleeding volume in LT(During surgery)
- Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed(During surgery)
- Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT(During the first 30 days postoperative LT)
- Measure the possible effect of the various pro- and antihaemostatic treatments on haemorrhagic and thrombotic complications in the first 30 days after LT surgery(During the first 30 days postoperative LT)
- Explore the links between thombothic events and the results of hemostatic tests (common biological tests and viscoelastic tests)(thombotic events observed during the first 30 days postoperative LT)
- Determine factors predicting transfusion of more than 2 pRBCs intraoperatively(During surgery)
- Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT(During surgery)
- Describe the use of blood products, blood-derived medicinal products and antifibrinolytics administered during each phase of LT and during the first 24 hours postoperatively. By listing all products administered.(During surgery)
- Determine the factors predicting the number of RBCs transfused within 24 hours post-LT(During 24 hours post-LT)
- Describe postoperative venous thrombotic events (deep vein thrombosis, pulmonary embolism, portal thrombosis) and arterial (graft artery thrombosis) during the first 30 days postoperative LT(During the first 30 days postoperative LT)
- To explore the links between bleeding or transfusion and the results of haemostatic tests (conventional biological and viscoelastic) in peri-operative LT. By comparing occurance of bleeding or transfusion and values of haemostatic tests.(During operation)