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

NCT ID: NCT02630095

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Portal Vein Thrombosis Liver Cirrhosis

Keywords

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anticoagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control.

No anticoagulation，just routine follow up.

Group Type OTHER

Doppler ultrasound and CT

Intervention Type DEVICE

all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。

Anticoagulation

Nadroparin Calcium and Warfarin

Group Type EXPERIMENTAL

Nadroparin Calcium and Warfarin

Intervention Type DRUG

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.

Doppler ultrasound and CT

Intervention Type DEVICE

all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。

Interventions

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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.

Intervention Type DRUG

Doppler ultrasound and CT

all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Pudong New Area Gongli Hospital

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Chen

Director of department of Gastroenterology, Zhongshan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyao Chen, Professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

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Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Shiyao Chen, Professor

Role: CONTACT

Phone: 86-13601767310

Email: [email protected]

Other Identifiers

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CSY-LSX02-2015

Identifier Type: -

Identifier Source: org_study_id