The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT

December 14, 2015 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

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.

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. 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 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
        • Shanghai Zhongshan Hospital

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 or other cancer;
  • 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 x10^9/L);
  • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control.
No anticoagulation，just routine follow up.
Device: Doppler ultrasound and CT
all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。
EXPERIMENTAL: Anticoagulation
Nadroparin Calcium and Warfarin
Device: Doppler ultrasound and CT
all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。
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, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion，an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate
Time Frame: through study completion，an average of 18 months
The investigators observe the variceal rebleeding events during the study
through study completion，an average of 18 months
Incidence rate of complications
Time Frame: through study completion，an average of 18 months
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
through study completion，an average of 18 months

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Eastern Hepatobiliary Surgery Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Shanghai Pudong New Area Gongli 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

December 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (ESTIMATE)

December 15, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-LSX02-2015

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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