Liver CirrhosisNCT03171727
Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
A study testing low molecular weight heparin in people with Liver Cirrhosis and Portal Hypertension, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension
- What is being tested?
- low molecular weight heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of liver cirrhosis
- Technical success of TIPS was achieved.
Who cannot join
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- Budd-Chiari syndrome
- Pregnancy
- Contradictions to anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West china Hospital
Chengdu
xuefeng luo, 02885422311, luo_xuefeng@yeah.net
About this study
Official title: 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.
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Being tested
- low molecular weight heparin
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight heparinDrug
After TIPS procedure was performed, low molecular weight heparin was given for three days.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | After TIPS procedure was performed, low molecular weight heparin was given for three days. Receives: Drug: low molecular weight heparin |
| control group | No intervention | After TIPS procedure was performed, no low molecular weight heparin was given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIPS patency rate
Analysis
Measured: one year
Secondary outcomes (2)
LMWH-related complication
Analysis
Measured: one month
Mortality rate
Analysis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017
- Primary completion15 May 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
- Investigators
- xuefeng luo, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171727
- Sponsor's protocol ID
- LMWH-TIPS
- Status last verified
- Jan 2019
- First submitted
- 26 May 2017
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction
- ClinicalTrials.gov ID
- NCT03171727
- Acronym / sponsor ID
- LMWH-TIPS
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: low molecular weight heparinAfter TIPS procedure was performed, low molecular weight heparin was given for three days. |
| control group | No intervention | –After TIPS procedure was performed, no low molecular weight heparin was given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of liver cirrhosis
- Technical success of TIPS was achieved.
Key exclusion criteria (5 listed)
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- Budd-Chiari syndrome
- Pregnancy
- Contradictions to anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low molecular weight heparinAfter TIPS procedure was performed, low molecular weight heparin was given for three days. | Drug | study group |
Primary outcome
TIPS patency rate
Time frame: one year
Analysis
2 secondary outcomes
LMWH-related complication
Time frame: one month
Mortality rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xuefeng luo principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low molecular weight heparin in people with Liver Cirrhosis and Portal Hypertension, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuefeng luo (02885422311, luo_xuefeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIPS patency rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.