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

Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis:A Zelen-design Multicenter Randomized Controlled Trial

Sponsors

Lead Sponsor: Shanghai Zhongshan Hospital

Collaborator: 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

Source Shanghai Zhongshan Hospital
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

Overall Status Unknown status
Start Date 2015-12-01
Completion Date 2018-09-01
Primary Completion Date 2018-09-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Recanalization rate of PVT through study completion,an average of 18 months
Secondary Outcome
Measure Time Frame
Rebleeding rate through study completion,an average of 18 months
Incidence rate of complications through study completion,an average of 18 months
Enrollment 96
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nadroparin Calcium and Warfarin

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.

Arm Group Label: Anticoagulation

Intervention Type: Device

Intervention Name: Doppler ultrasound and CT

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

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Shiyao Chen, Professor Study Director Shanghai Zhongshan Hospital
Overall Contact

Last Name: Shiyao Chen, Professor

Phone: 86-13601767310

Email: [email protected]

Location
Facility: Shanghai Zhongshan Hospital
Location Countries

China

Verification Date

2015-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shanghai Zhongshan Hospital

Investigator Full Name: Shiyao Chen

Investigator Title: Director of department of Gastroenterology, Zhongshan Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control.

Type: Other

Description: No anticoagulation,just routine follow up.

Label: Anticoagulation

Type: Experimental

Description: Nadroparin Calcium and Warfarin

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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