Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

NCT ID: NCT03171727

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-12-30

Brief Summary

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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

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Conditions

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Liver Cirrhosis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type EXPERIMENTAL

low molecular weight heparin

Intervention Type DRUG

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low molecular weight heparin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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luo xuefeng

attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xuefeng luo

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

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West china Hospital

Chengdu, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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xuefeng luo

Role: CONTACT

02885422311

Facility Contacts

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xuefeng luo

Role: primary

02885422311

Other Identifiers

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LMWH-TIPS

Identifier Type: -

Identifier Source: org_study_id

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