Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Portal Hypertension
• Intervention / Treatment: Drug: low molecular weight heparin

• Study Type: Interventional
• Enrollment (Anticipated): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Recruiting
    • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; After TIPS procedure was performed, low molecular weight heparin was given for three days.	Drug: low molecular weight heparin; After TIPS procedure was performed, low molecular weight heparin was given for three days.
No Intervention: control group; After TIPS procedure was performed, no low molecular weight heparin was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIPS patency rate	Analysis	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LMWH-related complication	Analysis	one month
Mortality rate	Analysis	one year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 15, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: LMWH-TIPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No