Anticoagulation for Advanced Cirrhotic Patients After TIPS
NCT ID: NCT03005444
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
254 participants
INTERVENTIONAL
2017-06-14
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
NCT01370161
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
NCT01326949
TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis
NCT02119988
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
NCT01410591
Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
NCT03171727
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anticoagulation
Rivaroxaban：10mg/d for 2 years
Rivaroxaban
10mg/day, for 2 years
Non-anticoagulated
No anticoagulants will be used.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivaroxaban
10mg/day, for 2 years
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female patients with an age of 18 to 75 years
* Liver cirrhosis.
* History of variceal bleeding \> 5 days
* Presence of ascites
* Successful TIPS
* Use of Viatorr stent
* Child-Pugh score within B7-C13
* Bilirubin level of 3 mg/dL or less (51.3 umol/L)
Patients who meet the following criteria at the time of screening will be excluded:
* Hepatocellular carcinoma or other intrahepatic/extrahepatic cancers.
* Spontaneous overt hepatic encephalopathy.
* Previous or current portal venous system thrombosis.
* Budd-Chiari syndrome.
* Known coagulation disorder besides liver cirrhosis.
* Severe thrombocytopenia \<15,000 platelets/dl.
* Peptic ulcer disease in the last 6 months.
* Unstable angina or myocardial infarction (MI) within the past 6 months before randomization.
* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
* Uncontrolled hypertension.
* Prior liver transplantation or candidates for liver transplantation.
* History of shunting surgery or TIPS before randomization.
* Pregnancy or breastfeeding
* Poor compliance
* Participation in another clinical trial
* Close affiliation with the investigational site.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Air Force Military Medical University, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guohong Han
MD，PhD，Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital Affiliated to Southern Medical University
Guanzhou, Guangdong, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, China
The First Affiliated Hospital, Air Force Medical University
Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APPROACH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.