Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Sichuan University

Status: Unknown

Conditions: Portal Hypertension; Liver Cirrhosis

Treatments: Drug: low molecular weight heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03171727

LMWH-TIPS

Details and patient eligibility

About

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.

Enrollment: 117 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

study group

Experimental group

Description:

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

Treatment:

Drug: low molecular weight heparin

control group

No Intervention group

Description:

After TIPS procedure was performed, no low molecular weight heparin was given.