跳至主要内容
临床试验/NCT04421924
NCT04421924招募中不适用

Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
39
试验地点
2
主要终点
blood product requirement

研究概览

简要总结

Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective

详细描述

Transjugular intrahepatic portosystemic shunt (TIPS) is a very effective procedure to treat complications of portal hypertension in liver cirrhosis. TIPS implantation is indicated in cirrhotic patients to treat or prevent portal hypertensive bleeding and to treat refractory ascites.

During this procedure an artificial connection between portal vein and hepatic vein is placed via an image-guided endovascular approach. Although the procedure is very effective and reasonably safe, several complications can occur.

Due to the underlying cirrhosis, morbidity and mortality of TIPS is high, with a 30-day mortality between 7 and 20%. Procedural site complications (transhepatic and transvenous access), bleeding, development of hepatic encephalopathy or other organ complications and stent complications comprise a considerable risk to the patients, however, the improvement of mortality, renal function and liver function outweighs the risks of the procedure. Optimal patient selection and preoperative preparation is crucial to avoid complications of this procedure.

In liver cirrhosis, coagulation disturbances are common. In hepatic insufficiency, a balanced reduction in the levels of most of pro- and anticoagulant proteins produced in the liver does not impair thrombin generation until levels are quite low. However, the ability of the coagulation system to tolerate or recover from an insult is markedly impaired in liver disease. This allows the coagulation system to be more easily tipped into a state favouring either haemorrhage or thrombosis. The American Gastroenterology Association has recently published best practice advices to manage coagulation in cirrhosis. This review concludes that commonly used global coagulation tests are not optimal to assess the risk of bleeding in cirrhosis. A randomized controlled trial showed, that the use of thrombelastography (TEG) to assess coagulation in cirrhosis resulted in a significantly lower usage of blood products with no increase in bleeding rates.

The bleeding risk for TIPS implantation is not well studied, ranging from 0.6-4.3% of fatal bleeding complications in older uncontrolled case series. No evidenced-based recommendations exist for the correction of coagulation abnormalities before TIPS - and the few existing recommendations are not backed with evidence but rather "eminence based". Currently, global tests of coagulation (prothrombin time and platelet count) are used to guide coagulation correction. Mostly, cut-offs without sufficient evidence (PT >50%/ INR >1.8 and platelets >50 G/L) are used for correction of coagulation.

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
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

入选标准

  • Liver cirrhosis
  • >18 years
  • Indication for TIPS implantation
  • Ability to sign informed consent

排除标准

  • Contraindications against TIPS implantation
  • Hepatocellular carcinoma BCLC D
  • Ongoing bleeding
  • pre-existing anticoagulant therapy at time of inclusion
  • administration of blood products within 1 week prior to the enrolment
  • Other malignancies that lead to an impaired 90-day survival
  • Inherit blood clotting disorders
  • Hepatic encephalopathy grade 3 or 4
  • any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol

结局指标

主要结局

blood product requirement

时间窗: 2 days

Amount of blood products (coagulation factors and platelet transfusions) transfused for pre-interventional correction of coagulation status

次要结局

  • Factor XIII(2 days)
  • complications(90 days)
  • Bleeding(90 days)
  • Modified TIPS Score (MOTS)(90 days)
  • Mortality(90 days)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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