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

Primary Purpose

Portal Vein Thrombosis, Liver Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nadroparin Calcium and Warfarin
Doppler ultrasound and CT
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Vein Thrombosis focused on measuring anticoagulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control.

Anticoagulation

Arm Description

No anticoagulation，just routine follow up.

Nadroparin Calcium and Warfarin

Outcomes

Primary Outcome Measures

Recanalization rate of PVT
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.

Secondary Outcome Measures

Rebleeding rate
The investigators observe the variceal rebleeding events during the study
Incidence rate of complications
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.

Full Information

First Posted
December 8, 2015
Last Updated
December 14, 2015
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02630095
Brief Title
The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT
Official Title
Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Thrombosis, Liver Cirrhosis
Keywords
anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control.
Arm Type
Other
Arm Description
No anticoagulation，just routine follow up.
Arm Title
Anticoagulation
Arm Type
Experimental
Arm Description
Nadroparin Calcium and Warfarin
Intervention Type
Drug
Intervention Name(s)
Nadroparin Calcium and Warfarin
Intervention Description
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
Device
Intervention Name(s)
Doppler ultrasound and CT
Intervention Description
all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。
Primary Outcome Measure Information:
Title
Recanalization rate of PVT
Description
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.
Time Frame
through study completion，an average of 18 months
Secondary Outcome Measure Information:
Title
Rebleeding rate
Description
The investigators observe the variceal rebleeding events during the study
Time Frame
through study completion，an average of 18 months
Title
Incidence rate of complications
Description
The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
Time Frame
through study completion，an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, Professor
Phone
86-13601767310
Email
chen.shiyao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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

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