Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Amount of blood product (in milliliter) transfused during liver transplantation.
研究概览
简要总结
In current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with ROTEM® depending on practitioner choice and availability of materials. In this context, the ROTEM® is used since over 2 years by anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon, France.
Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by PT and aPTT measures. Management of intraoperative hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.
This technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. Randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients >=18 years of age
- •Patients undergoing orthotopic liver transplantation in the Croix-Rousse Hospital within 24 months after inclusion and who have received clear information and who are not opposed to the participation in the study
- •Patients affiliated to a social security system or similar
- •Patients not subject to a measure of legal protection
排除标准
- •Opposition to participation in the study
- •Patients <18 years of age
- •Patients who participated in the previous month to another study protocol
- •Pregnant women or breast-feeding
- •Not affiliated to a social security system
- •Patients with hemostasis pathology (hemophilia, ...)
结局指标
主要结局
Amount of blood product (in milliliter) transfused during liver transplantation.
时间窗: During time of liver transplantation an average of 9 hours.
Assessing the impact of intraoperative management of coagulation by ROTEM® compared to the conventional management (standard coagulation profile) on the amount of blood product units (in milliliter) transfused during liver transplantation.
次要结局
- Occurrence of thrombotic complication.(within 48 first hours after liver transplantation.)
- Occurrence of serious respiratory complication.(within 48 first hours after liver transplantation.)
- Occurrence of serious infectious complication(within 48 first hours after liver transplantation.)