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NCT03171727 Clinical Trial

Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Liver Cirrhosis Clinical Trial

Official title:
Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03171727
Other study ID # LMWH-TIPS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date December 30, 2019

Study information
Verified date January 2019
Source West China Hospital
Contact xuefeng luo
Phone 02885422311
Email luo_xuefeng@yeah.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 117
Est. completion date December 30, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• low molecular weight heparin
After TIPS procedure was performed, low molecular weight heparin was given for three days.

Locations
Country Name City State
China West china Hospital Chengdu

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary TIPS patency rate Analysis one year
Secondary LMWH-related complication Analysis one month
Secondary Mortality rate Analysis one year
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