Portal Vein ThrombosisPhase 4NCT02630095
The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT
A Phase 4 study testing Nadroparin Calcium and Warfarin and Doppler ultrasound and CT in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality. 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 and Doppler ultrasound and CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2018
- 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 or other cancer;
- 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 x10^9/L);
- 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.
About this study
Official title: Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial
The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.
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. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator 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, Doppler ultrasound and CT
- Keywords
- anticoagulation
- 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, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous.
Doppler ultrasound and CTDevice
all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。
| Study group | Role | What they receive |
|---|---|---|
| Control. | Other | No anticoagulation，just routine follow up. Receives: Device: Doppler ultrasound and CT |
| Anticoagulation | Experimental | Nadroparin Calcium and Warfarin Receives: Drug: Nadroparin Calcium and Warfarin; Device: Doppler ultrasound and CT |
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 and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled，untill the end of the study.
Measured: through study completion，an average of 18 months
Secondary outcomes (2)
Rebleeding rate
The investigators observe the variceal rebleeding events during the study
Measured: through study completion，an average of 18 months
Incidence rate of complications
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
Measured: through study completion，an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (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
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
- 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
- NCT02630095
- Sponsor's protocol ID
- CSY-LSX02-2015
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02630095
- Acronym / sponsor ID
- CSY-LSX02-2015
- Conditions
- Portal Vein Thrombosis, Liver Cirrhosis
- Keywords
- anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
- Study start
- Dec 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Dec 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.
The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.
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. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator 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. | Other | Device: Doppler ultrasound and CTNo anticoagulation，just routine follow up. |
| Anticoagulation | Experimental | Drug: Nadroparin Calcium and Warfarin, Device: Doppler ultrasound and CTNadroparin 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 or other cancer;
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, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous. | Drug | Anticoagulation |
| Doppler ultrasound and CTall patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。 | Device | Anticoagulation, Control. |
Primary outcome
Recanalization rate of PVT
Time frame: through study completion，an average of 18 months
Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled，untill the end of the study.
2 secondary outcomes
Rebleeding rate
Time frame: through study completion，an average of 18 months
Incidence rate of complications
Time frame: through study completion，an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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 and Doppler ultrasound and CT 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 15 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: through study completion，an average of 18 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 15 Dec 2015.