Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Units of packed red blood cells (PRBCs)
研究概览
简要总结
A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.
详细描述
Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.
The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.
Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.
Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.
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
- 否
入选标准
- •all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.
排除标准
- •acute liver failure
- •age under 18
- •combined transplant
- •re transplantation less than 30 days
- •incomplete medical records, more than 20% of missing data.
结局指标
主要结局
Units of packed red blood cells (PRBCs)
时间窗: intraoperative
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.
次要结局
- mortality(30 days)
- Sepsis(During intensive care unit)
- Intensive care unit(up to 30 days)
- Acute respiratory distress syndrome(During intensive care unit)
- Mechanical ventilation(During intensive care unit)
研究者
Luiz Henrique Ide Yamauchi
Physician
Hospital Israelita Albert Einstein