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

Fudan University

Status and phase

Unknown

Phase 4

Conditions

Liver Cirrhosis

Portal Vein Thrombosis

Treatments

Drug: Nadroparin Calcium and Warfarin

Study type

Interventional

Funder types

Other

Identifiers

NCT02398357

CSY-LSX-2015

Details and patient eligibility

About

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.

Full 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

Enrollment

96 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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;
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.