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Trial record 95 of 990 for:    Heparin sodium

Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

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ClinicalTrials.gov Identifier: NCT03171727
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Portal Hypertension Drug: low molecular weight heparin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. TIPS patency rate [ Time Frame: one year ]
    Analysis


Secondary Outcome Measures :
  1. LMWH-related complication [ Time Frame: one month ]
    Analysis

  2. Mortality rate [ Time Frame: one year ]
    Analysis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171727


Contacts
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Contact: xuefeng luo 02885422311 luo_xuefeng@yeah.net

Locations
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China
West china Hospital Recruiting
Chengdu, China
Contact: xuefeng luo    02885422311    luo_xuefeng@yeah.net   
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: xuefeng luo Sichuan University

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Responsible Party: luo xuefeng, attending doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT03171727     History of Changes
Other Study ID Numbers: LMWH-TIPS
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Liver Cirrhosis
Hypertension, Portal
Liver Diseases
Digestive System Diseases
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action