The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis

December 8, 2015 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Shiyao Chen, MD
        • Sub-Investigator:
          • Shenxin Lu
        • Sub-Investigator:
          • Jian Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No anticoagulation，just routine follow-up
Experimental: Anticoagulation
Nadroparin Calcium and Warfarin
Drug: Nadroparin Calcium and Warfarin
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recanalization rate of PVT
Time Frame: 8 weeks
Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate
Time Frame: 8 weeks
The investigators observe the variceal rebleeding events during 8 weeks.
8 weeks
Incidence rate of complications
Time Frame: 8 weeks
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-LSX-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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