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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02630095
• Other study ID #: CSY-LSX02-2015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 8, 2015
• Last updated: December 14, 2015
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13601767310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Device:
• Doppler ultrasound and CT
all patient will take Doppler ultrasound examination every 3 months ;Abdominal CT will be done every 6 months?

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Eastern Hepatobiliary Surgery Hospital, Gongli Hospital of Shanghai Pudong District, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion,an average of 18 months	No
Secondary	Rebleeding rate	The investigators observe the variceal rebleeding events during the study	through study completion,an average of 18 months	No
Secondary	Incidence rate of complications	The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.	through study completion,an average of 18 months	Yes