Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection

Hypertension Clinical Trial

— ESWAPH  

Official title:

Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247414
• Other study ID #: YZUC-002
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: April 2018

Study information

• Verified date: March 2019
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

Description:

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A clinical, radiological or histologic diagnosis of cirrhosis of any etiology

• Splenomegaly with secondary hypersplenism

• Bleeding portal hypertension

• INo evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT

• Informed consent to participate in the study

Exclusion Criteria:

• Hepatocellular carcinoma or any other malignancy

• Hypercoagulable state other than the liver disease related

• DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs

• Base line INR >2

• Child-Pugh grade C

• Recent peptic ulcer disease

• History of Hemorrhagic stroke

• Pregnancy

• Uncontrolled Hypertension

• Age>75 yrs

• Human immunodeficiency virus (HIV) infection

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Status;Splenectomy
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Warfarin
From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.
• Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
• Aspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
• Low Molecular Weight Heparin
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.

Locations

Country	Name	City	State
China	Clinical Medical College of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization		3 years
Secondary	Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups		3 years
Secondary	Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups		3 years
Secondary	Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection		3 years
Secondary	Proportions of patients who will suffer from hepatocellular carcinoma in both groups		3 years
Secondary	Overall survival in both groups		3 years