Hypertension Clinical Trial
— ESWAOfficial title:
Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
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 with Hypersplenism after Laparoscopic Splenectomy.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
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, Platelet count < 50*10^9/L - No 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 - F2 varices with red whale marks or F3 varices - Bleeding portal hypertension - Human immunodeficiency virus (HIV) infection |
Country | Name | City | State |
---|---|---|---|
China | Clinical Medical College of Yangzhou University | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Yangzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportions of patients who will suffer from 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 | 3 years | ||
Secondary | Overall survival in both groups | 3 years |
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