Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Not Applicable

• Conditions: Portal Hypertension; Liver Cirrhosis
• Interventions: Drug: low molecular weight heparin

• Registration Number: NCT03171727
• Lead Sponsor: West China Hospital

Brief Summary

Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation. Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used during TIPS creation was not answered. The present study was designed to evaluate the effect of short-term use of LMWH on early TIPS dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Study Start: 2017-06-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08
• Primary Completion: 2019-05-15
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. Diagnosis of liver cirrhosis
2. Technical success of TIPS was achieved.

Exclusion Criteria

1. Non-cirrhotic portal hypertension
2. Portal vein thrombosis
3. Budd-Chiari syndrome
4. Pregnancy
5. Contradictions to anticoagulation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	low molecular weight heparin	After TIPS procedure was performed, low molecular weight heparin was given for three days.

Primary Outcome Measures

Name	Time	Method
TIPS patency rate	one year	Analysis

Secondary Outcome Measures

Name	Time	Method
Mortality rate	one year	Analysis
LMWH-related complication	one month	Analysis

Trial Locations

Locations (1)

West china Hospital; 🇨🇳 Chengdu, China