Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis

February 13, 2017 updated by: Guohong Han, Air Force Military Medical University, China

Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis: a Single Center Prospective Randomized Controlled Trial

The purpose of this study is to determine the safety and efficacy of anticoagulation in the treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Portal vein thrombosis is a common complication of liver cirrhosis, especially at the decompensated or advanced stage. The reported prevalence was 10-25% by ultrasound. The effect of PVT on the natural history of liver cirrhosis is not clear, especially the non-occlusive PVT. According to a recent large prospective study (n=1243), the development of PVT and the progression of liver disease are two separate consequences of a common mechanism. It was hypothesized that the activation of coagulation factors in the cirrhotic liver or the portal venous system is the common mechanism for the progression of liver disease, on the one hand, and the development of PVT on the other. A recent randomized clinical trial has shown that enoxaparin therapy for 48 weeks can prevent disease progression and PVT in patients with Child class B-C cirrhosis. Besides, emerging evidences have shown that 30-50% of patients with cirrhosis and partial PVT can achieve this spontaneous recanalization. So what the role of anticoagulation played in the management of PVT in liver cirrhosis is still contraversal. Anticoagulation therapy was also shown very effective with a high recanalization rate of 42-100%. But this data was mostly derived from retrospective, non-randomized study and no well-designed randomized controlled trial has been conducted to evaluate the safety and efficacy of anticoagulation for non-occlusive PVT.

Study Type

Interventional

Phase

  • Not Applicable

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:

  • Informed consent was obtained
  • liver cirrhosis
  • Non-occlusive portal vein thrombosis
  • No history of variceal bleeding or receive endoscopy or β-blocker for the prevention of patients with G3 or G2 with red marks within 3 months before enrollment
  • No plan for liver transplantation
  • Age between 18 and 70
  • Child-Pugh score ≤ 11

Exclusion Criteria:

  • Acute PVT
  • Fibrotic cord of PV
  • Isolated splenic vein thrombosis or isolated superior mesenteric vein thrombosis
  • Extensive superior mesenteric vein thrombosis involving the distal part
  • Known coagulation disorder besides liver cirrhosis
  • HCC or other malignant tumor
  • Patients with G2 varices with red mark or G3 but did not underwent any preventive endoscopy or β-blockers
  • Platelet count < 10×109/L
  • Receive contraceptive, anticoagulation or antiplatelet drug
  • Receiving thrombolysis treatment
  • Receiving TIPS or shunting surgery
  • Bleeding tendency
  • Recent gastrointestinal bleeding like digestive ulcer or hemorrhagic stroke
  • Severe portal hypertension，for example, refractory ascite or acute variceal bleeidng
  • Spontaneous bacterial peritonitis
  • Severe cardiovascular disorder, endocrine disorder, or mental disease
  • Major surgery within 6 months
  • History of organ transplantation
  • Pregnancy or breast-feeding
  • History of HIV
  • Poor compliance

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
Experimental: Anticoagulation
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,along with Nadroparin Calcium 85IU／kg，subcutaneous, q12h,for the first 5 days at least.
Drug: Nadroparin Calcium and Warfarin
Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year
No Intervention: Non-anticoaglated
No anticoagulatoin or other treatment for PVT will be used in this group of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Liver Decompensation as Assessed by Cummulative Rate
Time Frame: 2
2
Number of Participants Who Show Improvement in Child-Pugh score > 2 Points
Time Frame: 2 years
Child-Pugh Scores range from 5 to 15
2 years
Number of Participants Who Show Improvement in MELD Score > 5 points
Time Frame: 2 year
2 year
Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography
Time Frame: 2 years
2 years
Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate
Time Frame: 2 years
2 years
Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate
Time Frame: 2 years
2 years
Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model
Time Frame: 2 years
2 years
Number of Participants With Major Bleeding as Assessed by Cummulative Rate
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Guohong Han, PhD,MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Primary Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 15, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-AT-1

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.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Nadroparin Calcium and Warfarin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe