Clinical Trials Logo

Clinical Trial Summary

Recent studies demonstrated that liver cirrhosis was associated with a hypercoagulability state. Besides, bacterial translocation plays an important role in the pathogenesis and complications in patients with decompensated cirrhosis, including infections as well as hepatic encephalopathy and hepatorenal syndrome.

A recent prospective study in a group of 70 patients with liver cirrhosis (Child B and C stages up to 10 points) who were randomized to receive enoxaparin for a year (n = 34) vs no intervention (n = 36) showed that anticoagulant treatment with enoxaparin is safe and effective, significantly reducing risk of PVT development and liver decompensation, markedly improving overall survival. This study provides exciting preliminary data regarding the potential use of prophylactic anticoagulation in improving clinical outcomes in cirrhosis, beyond the prevention of portal vein thrombosis. This study suggested that the effect was partly due to a direct effect of reducing BT and levels of proinflammatory cytokines. However, this study included few patients, was not double blind, and did not have a placebo group. Therefore, despite the spectacular results, the use of prophylactic anticoagulant therapy has not become routine practice in patients with cirrhosis and more studies are needed to assess the potential usefulness of anticoagulation in improving the prognosis of liver cirrhosis.

Transjugular intrahepatic portosystemic shunts (TIPS) are now routinely used to treat the complications of portal hypertension, such as variceal bleeding and refractory ascites. TIPS is the most effective method to prevent rebleeding, however, it is burdened with increased risk of hepatic encephalopathy and deterioration of liver function in patients with advanced cirrhosis. Notably, TIPS can not only relieve portal pressure but also can redirect the portal blood flow through the shunt directly into the systemic circulation which can cause systemic hemodynamic changes.

Given the preliminary data suggesting a beneficial effect of prophylactic anticoagulation with LMWH in cirrhotic patients, this multicenter randomized controlled study attempts to demonstrate the effect of long term LMWH therapy after TIPS on survival in cirrhotic patients with variceal bleeding.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03005444
Study type Interventional
Source Fourth Military Medical University
Contact Guohong Han, MD,Ph.D
Phone +86-29-84771537
Email [email protected]
Status Recruiting
Phase N/A
Start date June 14, 2017
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04533932 - Endosonographic Shear Wave Elastography for Liver Stiffness
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT04874350 - A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia Phase 2
Not yet recruiting NCT02710227 - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis N/A
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting NCT02551250 - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Terminated NCT02311985 - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial N/A
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01618890 - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding Phase 3
Terminated NCT01686880 - Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver Phase 2
Recruiting NCT01071746 - Predictive Utility of DASIMAR as a Prognostic Biomarker in Acute-on-chronic Liver Failure (ACLF) N/A
Recruiting NCT01358123 - Value of Von Willebrand Factor in Portal Hypertension N/A
Completed NCT00679692 - Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease N/A
Withdrawn NCT00381017 - Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371) Phase 3