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CirrhosisPhase 4ESWAPHNCT02247414

Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection

A Phase 4 study testing Warfarin, Dipyridamole and Aspirin in people with Cirrhosis and Hypertension, run by Yangzhou University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhosis, Hypertension, Status;Splenectomy
What is being tested?
Warfarin, Dipyridamole and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
Sep 2014to Apr 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 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
  • Bleeding portal hypertension
  • INo 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 11Show fewer
  • History of Hemorrhagic stroke
  • Pregnancy
  • Uncontrolled Hypertension
  • Age>75 yrs
  • Human immunodeficiency virus (HIV) infection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Clinical Medical College of Yangzhou University

    Yangzhou, Jiangsu, 225001

Other trials in China

About this study

Official title: Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

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 after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

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.

Being tested
Warfarin, Dipyridamole, Aspirin, Low Molecular Weight Heparin
Keywords
Cirrhosis, Hypertension, venous thrombosis, Warfarin, Splenectomy, Azygoportal Disconnection, Laparoscopy
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 groups in NCT02247414
Study groupRoleWhat they receive
Warfarin with dipyridamoleExperimentalFrom 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 dipyridamoleActive comparatorFrom 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.

  1. Proportions of patients who will suffer 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)

  1. Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups

    Measured: 3 years

  2. Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups

    Measured: 3 years

  3. 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

  4. Proportions of patients who will suffer from hepatocellular carcinoma in both groups

    Measured: 3 years

  5. 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.

  1. First posted25 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2017
  4. Study completionApr 2018

Resources

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
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247414
Sponsor's protocol ID
YZUC-002
Acronym
ESWAPH
Status last verified
Mar 2019
First submitted
18 Sep 2014
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wu LF, Bai DS, Shi L, Jin SJ, Zhou BH, Jiang GQ. Predictors of portal vein thrombosis after laparoscopic splenectomy and azygoportal disconnection in hepatitis B cirrhosis: a prospective study. Surg Endosc. 2022 Jun;36(6):4090-4098. doi: 10.1007/s00464-021-08730-5. Epub 2021 Sep 13.

    PubMed 34518951

  • Bai DS, Zhou BH, Qian JJ, Zhang C, Jin SJ, Jiang GQ. Effects of laparoscopic splenectomy and azygoportal disconnection on liver synthesis function and cirrhosis: a 2-year prospective study. Surg Endosc. 2020 Nov;34(11):5074-5082. doi: 10.1007/s00464-019-07307-7. Epub 2019 Dec 9.

    PubMed 31820157

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 5 inclusion and 11 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: finished, as of the sponsor's last update on 29 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportions of patients who will suffer 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?

On the ClinicalTrials.gov record for NCT02247414, which also lists 2 linked publications.

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 29 Mar 2019.

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