Cirrhosis, Hypertension, Status; Splenectomy, Venous Thrombosis
Conditions
Keywords
Warfarin, Portal Vein, Anticoagulants, Cirrhosis, Hypertension, Venous Thrombosis, Splenectomy
Brief 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 with Hypersplenism after Laparoscopic Splenectomy.
Detailed 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.
Interventions
DRUGWarfarin
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.
DRUGDipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
DRUGAspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
DRUGLow 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.
Sponsors
Yangzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups | 3 years |
| Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups | 3 years |
| 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 |
| Proportions of patients who will suffer from hepatocellular carcinoma | 3 years |
| Overall survival in both groups | 3 years |
Countries
China
Contacts
Primary ContactGuo-Qing Jiang, MS
Backup ContactDou-sheng Bai, MD
Outcome results
None listed