The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398357
• Other study ID #: CSY-LSX-2015
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2015
• Last updated: December 8, 2015
• Start date: March 2015
• Est. completion date: December 2017

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

To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.

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.We need more high-quality research such as randomized controlled trials. This is a Zelen-designed randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then we 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: Recruiting
• Enrollment: 96
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• 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;

• 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 x103/uL);

• 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,alone with Nadroparin Calcium 4100IU/d,subcutaneous, when taking endoscopy therapy .

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

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 before enrolled and after followed up for 8 weeks	8 weeks	No
Secondary	Rebleeding rate	The investigators observe the variceal rebleeding events during 8 weeks.	8 weeks	No
Secondary	Incidence rate of complications	The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.	8 weeks	Yes