Portal Vein ThrombosisPhase 4NCT02398357
The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis
A Phase 4 study testing Nadroparin Calcium and Warfarin in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Vein Thrombosis, Liver Cirrhosis
- What is being tested?
- Nadroparin Calcium and Warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70 years old;
- A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
- Diagnosed of Portal vein thrombosis;
- Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- Have undergone endoscopy to prevent variceal rebleeding.
Who cannot join
- Age <18 or >70 years;
- Portal vein thrombosis diagnosed before 6 months;
- Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;
- Pregnant or nursing;
- Hepatocellular carcinoma;
- Severe cardiopulmonary diseases or concomitant renal insufficiency;
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- cavernous transformation of the portal vein;
- Contradictions to endoscopy;
- Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count < 50 x103/uL);
- Taking immunosuppressive agent;
- Coagulation disorders other than the liver disease related;
- Variceal bleeding failed to control.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shenxin Lu, Doctor, 86-13611843734, 08301010239@fudan.edu.cn
Shiyao Chen, MD
About this study
Official title: A Zelen-design Randomized Controlled Trial of the Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis
To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.
Read the detailed description
The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality.We need more high-quality research such as randomized controlled trials. This is a Zelen-designed randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then we will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed
- Conditions
- Portal Vein Thrombosis, Liver Cirrhosis
- Being tested
- Nadroparin Calcium and Warfarin
- Keywords
- anticoagulation, Zelen-designed randomized controlled trial
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nadroparin Calcium and WarfarinDrug
Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,alone with Nadroparin Calcium 4100IU／d，subcutaneous, when taking endoscopy therapy .
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No anticoagulation，just routine follow-up |
| Anticoagulation | Experimental | Nadroparin Calcium and Warfarin Receives: Drug: Nadroparin Calcium and Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization rate of PVT
Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks
Measured: 8 weeks
Secondary outcomes (2)
Rebleeding rate
The investigators observe the variceal rebleeding events during 8 weeks.
Measured: 8 weeks
Incidence rate of complications
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao Chen, Professor, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398357
- Sponsor's protocol ID
- CSY-LSX-2015
- Status last verified
- Dec 2015
- First submitted
- 19 Mar 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Zelen-design Randomized Controlled Trial of the Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02398357
- Acronym / sponsor ID
- CSY-LSX-2015
- Conditions
- Portal Vein Thrombosis, Liver Cirrhosis
- Keywords
- anticoagulation, Zelen-designed randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- 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.
To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.
Detailed description
The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality.We need more high-quality research such as randomized controlled trials. This is a Zelen-designed randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then we will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No anticoagulation，just routine follow-up |
| Anticoagulation | Experimental | Drug: Nadroparin Calcium and WarfarinNadroparin Calcium and Warfarin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-70 years old;
- A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
- Diagnosed of Portal vein thrombosis;
- Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- Have undergone endoscopy to prevent variceal rebleeding.
Key exclusion criteria (12 listed)
- Age <18 or >70 years;
- Portal vein thrombosis diagnosed before 6 months;
- Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;
- Pregnant or nursing;
- Hepatocellular carcinoma;
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 |
|---|---|---|
| Nadroparin Calcium and WarfarinPatients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,alone with Nadroparin Calcium 4100IU／d，subcutaneous, when taking endoscopy therapy . | Drug | Anticoagulation |
Primary outcome
Recanalization rate of PVT
Time frame: 8 weeks
Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks
2 secondary outcomes
Rebleeding rate
Time frame: 8 weeks
Incidence rate of complications
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
Shiyao Chen, Professor study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nadroparin Calcium and Warfarin in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Shanghai Zhongshan 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 5 inclusion and 12 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 9 Dec 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiyao Chen, Professor (86-13601767310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recanalization rate of PVT (time frame: 8 weeks). 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 9 Dec 2015.