A Prospective, Randomized Study Evaluating the Effectiveness of Portal Hypertension Modulation in the Preoperative Period in Patients at Increased Risk of Massive Blood Loss During Liver Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of red blood cell units transfused during liver transplantation.
研究概览
简要总结
Liver transplantation is a procedure associated with an exceptionally high risk of blood loss. Liver failure, which is the most common indication for transplantation, not only leads to coagulation disorders but also to the development of portal hypertension. As a result, collateral circulation forms within the abdominal venous system, significantly increasing the risk of massive intraoperative blood loss. The number of intraoperatively transfused units of red blood cell concentrate is one of the main predictors of serious complications and postoperative mortality.
Patients with portal hypertension awaiting liver transplantation should be treated with non-selective β-blockers, which reduce pressure in the portal system. This is primarily justified by the need to prevent esophageal variceal bleeding, one of the most common causes of decompensation in chronic liver failure and a potential cause of death while awaiting liver transplantation.
According to the Baveno VII guidelines, if bleeding recurs despite the use of non-selective β-blockers, a transjugular intrahepatic portosystemic shunt (TIPS) should be considered. Significant reduction of portal pressure is observed in up to 50% of patients treated with propranolol and up to 75% with carvedilol. TIPS effectively prevents bleeding caused by portal hypertension.
However, recommendations for pre-transplant management of portal hypertension do not address the reduction of blood loss risk during liver transplantation. Previous studies evaluating the use of TIPS before transplantation primarily confirmed its safety and showed no significant increase in intraoperative risk. One analysis even suggested using TIPS in all patients with portal hypertension awaiting liver transplantation. Although some studies have addressed the issue of blood loss during transplantation, they were observational and retrospective, without distinguishing patients at particularly high risk of massive blood loss. So far, the effectiveness of TIPS in reducing blood loss during liver transplantation has not been confirmed-nor have studies reliably excluded such potential.
The objective of the study is to directly compare the effectiveness of two different methods of modulating portal hypertension in the context of the risk of massive blood loss during liver transplantation.
We hypothesize that the superior effectiveness of TIPS in significantly reducing portal hypertension may lead to a significant decrease in blood loss and the need for transfusion of blood products in patients at high risk of massive blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Qualification for elective liver transplantation from a deceased donor
- •Age ≥18 years
- •BMI between 18.5 kg/m² and 30 kg/m²
- •Informed consent to participate in the study
- •Clinically significant portal hypertension
- •At least 1 of the following risk factors for massive blood loss:
- •Re-transplantation
- •Previous surgery in the upper abdomen
- •History of esophageal variceal bleeding
- •History of spontaneous bacterial peritonitis
- •Planned thrombectomy during liver transplantation
排除标准
- •Heart failure (EF <50%)
- •Severe right ventricular failure
- •Severe pulmonary hypertension
- •Systemic infection
- •Portal vein thrombosis (Yerdel >1)
- •Severe coagulopathy (INR >5)
- •Thrombocytopenia <20,000/ml
- •Severe or uncontrolled encephalopathy (ammonia concentration >100 μmol/l)
- •Contraindication to TIPS
- •Contraindication to therapy with non-selective beta-blockers
- •Pregnancy
- •Lack of informed consent to participate in the study
研究组 & 干预措施
Non-selective beta blockers
Non-selective beta blockers for treatment of portal hypertension
干预措施: Non-selective beta-blockers (Drug)
Non-selective beta blockers + TIPS
Non-selective beta blockers and TIPS for treatment of portal hypertension
干预措施: Transjugular Intrahepatic Portosystemic Shunt (Procedure)
Non-selective beta blockers + TIPS
Non-selective beta blockers and TIPS for treatment of portal hypertension
干预措施: Non-selective beta-blockers (Drug)
结局指标
主要结局
Number of red blood cell units transfused during liver transplantation.
时间窗: Intraoperative
次要结局
- Portal vein blood flow(Intraoperative)
- Intraoperative blood loss(Intraoperative)
- Operation time(Intraoperative)
- Postoperative complications(Up to 90 days)
- Time of hospitalisation(Up to 90 days)
- Variceal bleeding(Preoperative)
- Overall survival(Up to 90 days)
