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
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJanuary 8, 2019
January 1, 2019
2 years
May 26, 2017
January 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
TIPS patency rate
Analysis
one year
Secondary Outcomes (2)
LMWH-related complication
one month
Mortality rate
one year
Study Arms (2)
study group
EXPERIMENTALAfter TIPS procedure was performed, low molecular weight heparin was given for three days.
control group
NO INTERVENTIONAfter TIPS procedure was performed, no low molecular weight heparin was given.
Interventions
After TIPS procedure was performed, low molecular weight heparin was given for three days.
Eligibility Criteria
You may qualify if:
- Diagnosis of liver cirrhosis
- Technical success of TIPS was achieved.
You may not qualify if:
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- Budd-Chiari syndrome
- Pregnancy
- Contradictions to anticoagulation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West china Hospital
Chengdu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xuefeng luo
Sichuan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending doctor
Study Record Dates
First Submitted
May 26, 2017
First Posted
May 31, 2017
Study Start
June 1, 2017
Primary Completion
May 15, 2019
Study Completion
December 30, 2019
Last Updated
January 8, 2019
Record last verified: 2019-01