CirrhosisPhase 4ESWANCT02238444
Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
A Phase 4 study testing Warfarin, Dipyridamole and Aspirin in people with Cirrhosis and Hypertension, run by Yangzhou University at 1 site in China.
Trial summary
The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism after Laparoscopic Splenectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Hypertension, Venous Thrombosis
- What is being tested?
- Warfarin, Dipyridamole and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2014to 30 Sep 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L
- No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
- Informed consent to participate in the study
Who cannot join
- Hepatocellular carcinoma or any other malignancy
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs
- Base line INR >2
- Child-Pugh grade C
- Recent peptic ulcer disease
Show all 13Show fewer
- History of Hemorrhagic stroke
- Pregnancy
- Uncontrolled Hypertension
- Age>75 yrs
- F2 varices with red whale marks or F3 varices
- Bleeding portal hypertension
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Luo-Jing Zhou, MD, 86-514-87373037, luojing76@163.com
Dou-Sheng Bai, MD
About this study
Official title: Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism after Laparoscopic Splenectomy.
Read the detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.
- Conditions
- Cirrhosis, Hypertension, Venous Thrombosis, Status; Splenectomy
- Keywords
- Warfarin, Portal Vein, Anticoagulants, Cirrhosis, Hypertension, Venous Thrombosis, Splenectomy
- Medical subject headings
- Fibrosis, Hypertension, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN
From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.
DipyridamoleDrug
Also called Gardoxin, Coribon, Curantyl, Dilaplus
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
AspirinDrug
Also called Acenterine, Acetard, Acetophen
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
Low Molecular Weight HeparinDrug
Also called Fraxiparine
From postoperative day 3, Patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin with dipyridamole | Experimental | From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus. Receives: Drug: Warfarin; Drug: Dipyridamole; Drug: Low Molecular Weight Heparin |
| Aspirin with dipyridamole | Active comparator | From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year. Receives: Drug: Dipyridamole; Drug: Aspirin; Drug: Low Molecular Weight Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients who will suffer from PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization
Measured: 3 years
Secondary outcomes (5)
Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups
Measured: 3 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
Measured: 3 years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection
Measured: 3 years
Proportions of patients who will suffer from hepatocellular carcinoma
Measured: 3 years
Overall survival in both groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start1 Sep 2014
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Yangzhou University
- Investigators
- Dou-Sheng Bai, MD, Study chair, Clinical Medical College of Yangzhou UniversityGuo-Qing Jiang, MS, Study director, Clinical Medical College of Yangzhou UniversityPing Chen, MD, Principal investigator, Clinical Medical College of Yangzhou UniversitySheng-Jie Jin, Principal investigator, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238444
- Sponsor's protocol ID
- YZUC-001
- Acronym
- ESWA
- Status last verified
- Dec 2018
- First submitted
- 4 Sep 2014
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
- ClinicalTrials.gov ID
- NCT02238444
- Acronym / sponsor ID
- ESWA / YZUC-001
- Conditions
- Cirrhosis, Hypertension, Venous Thrombosis, Status; Splenectomy
- Keywords
- Warfarin, Portal Vein, Anticoagulants, Cirrhosis, Hypertension, Venous Thrombosis, Splenectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 12 Sep 2014 (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 whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism after Laparoscopic Splenectomy.
Detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin with dipyridamole | Experimental | Drug: Warfarin, Drug: Dipyridamole, Drug: Low Molecular Weight HeparinFrom postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus. |
| Aspirin with dipyridamole | Active comparator | Drug: Dipyridamole, Drug: Aspirin, Drug: Low Molecular Weight HeparinFrom postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L
- No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
- Informed consent to participate in the study
Key exclusion criteria (13 listed)
- Hepatocellular carcinoma or any other malignancy
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs
- Base line INR >2
- Child-Pugh grade C
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 |
|---|---|---|
| WarfarinAlso: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFINFrom postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year. | Drug | Warfarin with dipyridamole |
| DipyridamoleAlso: Gardoxin, Coribon, Curantyl, DilaplusFrom postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months. | Drug | Aspirin with dipyridamole, Warfarin with dipyridamole |
| AspirinAlso: Acenterine, Acetard, AcetophenFrom postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year. | Drug | Aspirin with dipyridamole |
| Low Molecular Weight HeparinAlso: FraxiparineFrom postoperative day 3, Patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days. | Drug | Aspirin with dipyridamole, Warfarin with dipyridamole |
Primary outcome
Proportions of patients who will suffer from PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization
Time frame: 3 years
5 secondary outcomes
Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups
Time frame: 3 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
Time frame: 3 years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection
Time frame: 3 years
Proportions of patients who will suffer from hepatocellular carcinoma
Time frame: 3 years
Overall survival in both groups
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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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.
Dou-Sheng Bai, MD study chair
Clinical Medical College of Yangzhou University
Guo-Qing Jiang, MS study director
Clinical Medical College of Yangzhou University
Ping Chen, MD principal investigator
Clinical Medical College of Yangzhou University
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 Warfarin, Dipyridamole and Aspirin in people with Cirrhosis and Hypertension, run by Yangzhou University 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 4 inclusion and 13 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 2 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.
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 Guo-Qing Jiang, MS (86-514-87373272, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of patients who will suffer from PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization (time frame: 3 years). 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 2 Jan 2019.