Portal Vein ThrombosisNCT06319131
Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT
A study testing TIPS and Nadroparin in people with Portal Vein Thrombosis, run by Shanghai Zhongshan Hospital.
Trial summary
The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- TIPS and Nadroparin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 May 2026
- 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
- Diagnosed with liver cirrhosis
- Diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter.
- Consent to participate in the clinical trial and the signing of an informed consent form.
Who cannot join
- Presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation
- Patients with Child-Pugh C.
- Pregnant or lactating women.
- With a history of liver cancer or other malignancy.
- Severe heart, lung diseases, or significant renal dysfunction.
- Allergies to anticoagulant medications, uncontrolled hypertension, history of cerebral hemorrhage, discovery of gastrointestinal ulcers, ulcerative colitis, subacute bacterial endocarditis, or other contraindications to anticoagulant drugs.
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- On concomitant therapy of immunosuppressive drugs.
- With coagulation disorders other than liver disease.
- With active variceal bleeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Effectiveness of Nadroparin Versus Transjugular Intrahepatic Portosystemic Shunt in Cirrhotic Patients With Refractory Asymptomatic Portal Vein Thrombosis：a Multicenter, Randomized Controlled Trial
The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial
Read the detailed description
This research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (PVT) associated with liver cirrhosis. Building upon this, a randomized controlled study will be carried out for PVT patients with poor response to anticoagulant treatment. The study will compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) and prolonged anticoagulant therapy. The ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated PVT. This comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory PVT in liver cirrhosis.
- Conditions
- Portal Vein Thrombosis
- Being tested
- TIPS, Nadroparin
- Keywords
- portal vein thrombosis, liver cirrhosis, nadroparin, transjugular intrahepatic portosystemic shunt
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSProcedure or surgery
Using the transjugular approach, TIPS was created under local anesthesia. The first branch of the left or right portal vein (PV) was punctured by RUPS-100 set guided by digital subtraction angiography. After successful access into PV, direct portography was performed and all visible varices and/or concurrent spontaneous portosystemic shunts (SPSS) were embolized with coils and n-butyl cyanoacrylate. A polytetrafluoroethylene-covered stent (Viatorr Endoprosthesis, GORE and Associates, Flagstaff, Arizona, USA) with a diameter of 8 mm was implanted and fully dilated.
NadroparinDrug
Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h
| Study group | Role | What they receive |
|---|---|---|
| TIPS group | Experimental | The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt. Receives: Procedure: TIPS |
| Nadroparin group | Active comparator | The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy Receives: Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete recanalization rate of PVT
Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. The primary outcome is the complete recanalization.
Measured: 6 months
Secondary outcomes (3)
partial recanalization rate of PVT
Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. Partial recanalization is defined as decrease of PVT more than 50%.
Measured: 6 months
Bleeding rate
Bleeding events related to anticoagulant therapy. Bleeding events will be further classified into major and minor according to the established criteria outlined by the International Society of Thrombosis and Haemostasis
Measured: 6 months
Mortality
Survival analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, ShuGuang Hospital, Tongji Hospital, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
- Investigators
- Jian Wang, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319131
- Sponsor's protocol ID
- Tipharosis
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Nadroparin Versus Transjugular Intrahepatic Portosystemic Shunt in Cirrhotic Patients With Refractory Asymptomatic Portal Vein Thrombosis：a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06319131
- Acronym / sponsor ID
- Tipharosis
- Conditions
- Portal Vein Thrombosis
- Keywords
- portal vein thrombosis, liver cirrhosis, nadroparin, transjugular intrahepatic portosystemic shunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, ShuGuang Hospital, Tongji Hospital, Renmin Hospital of Wuhan University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 19 Mar 2024 (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.
The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial
Detailed description
This research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (PVT) associated with liver cirrhosis. Building upon this, a randomized controlled study will be carried out for PVT patients with poor response to anticoagulant treatment. The study will compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) and prolonged anticoagulant therapy. The ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated PVT. This comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory PVT in liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS group | Experimental | Procedure: TIPSThe cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt. |
| Nadroparin group | Active comparator | Drug: NadroparinThe cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with liver cirrhosis
- Diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter.
- Consent to participate in the clinical trial and the signing of an informed consent form.
Key exclusion criteria (9 listed)
- Presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation
- Patients with Child-Pugh C.
- Pregnant or lactating women.
- With a history of liver cancer or other malignancy.
- Severe heart, lung diseases, or significant renal dysfunction.
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 |
|---|---|---|
| TIPSUsing the transjugular approach, TIPS was created under local anesthesia. The first branch of the left or right portal vein (PV) was punctured by RUPS-100 set guided by digital subtraction angiography. After successful access into PV, direct portography was performed and all visible varices and/or concurrent spontaneous portosystemic shunts (SPSS) were embolized with coils and n-butyl cyanoacrylate. A polytetrafluoroethylene-covered stent (Viatorr Endoprosthesis, GORE and Associates, Flagstaff, Arizona, USA) with a diameter of 8 mm was implanted and fully dilated. | Procedure or surgery | TIPS group |
| NadroparinNadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h | Drug | Nadroparin group |
Primary outcome
complete recanalization rate of PVT
Time frame: 6 months
Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. The primary outcome is the complete recanalization.
3 secondary outcomes
partial recanalization rate of PVT
Time frame: 6 months
Bleeding rate
Time frame: 6 months
Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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.
Jian Wang, MD principal investigator
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TIPS and Nadroparin in people with Portal Vein Thrombosis, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 9 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jie CHEN, MD (8613764633539, chen.jie5@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete recanalization rate of PVT (time frame: 6 months). 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 21 Mar 2024.