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Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Primary Purpose

Liver Cirrhosis, Portal Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low molecular weight heparin
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • West china HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

TIPS patency rate
Analysis

Secondary Outcome Measures

LMWH-related complication
Analysis
Mortality rate
Analysis

Full Information

First Posted
May 26, 2017
Last Updated
January 7, 2019
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03171727
Brief Title
Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
Official Title
Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
After TIPS procedure was performed, low molecular weight heparin was given for three days.
Arm Title
control group
Arm Type
No Intervention
Arm Description
After TIPS procedure was performed, no low molecular weight heparin was given.
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin
Intervention Description
After TIPS procedure was performed, low molecular weight heparin was given for three days.
Primary Outcome Measure Information:
Title
TIPS patency rate
Description
Analysis
Time Frame
one year
Secondary Outcome Measure Information:
Title
LMWH-related complication
Description
Analysis
Time Frame
one month
Title
Mortality rate
Description
Analysis
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of liver cirrhosis Technical success of TIPS was achieved. Exclusion Criteria: Non-cirrhotic portal hypertension Portal vein thrombosis Budd-Chiari syndrome Pregnancy Contradictions to anticoagulation therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuefeng luo
Phone
02885422311
Email
luo_xuefeng@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xuefeng luo
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West china Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuefeng luo
Phone
02885422311
Email
luo_xuefeng@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

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