Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
Information source: Yangzhou University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Hypertension; Venous Thrombosis; Status; Splenectomy
Intervention: Warfarin (Drug); Dipyridamole (Drug); Aspirin (Drug); Low Molecular Weight Heparin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Yangzhou University Official(s) and/or principal investigator(s): Dou-Sheng Bai, MD, Study Chair, Affiliation: Clinical Medical College of Yangzhou University Guo-Qing Jiang, MS, Study Director, Affiliation: Clinical Medical College of Yangzhou University Ping Chen, MD, Principal Investigator, Affiliation: Clinical Medical College of Yangzhou University Sheng-Jie Jin, Principal Investigator, Affiliation: Clinical Medical College of Yangzhou University
Overall contact: Guo-Qing Jiang, MS, Phone: 86-514-87373272, Email: jgqing2003@hotmail.com
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.
Clinical Details
Official title: Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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
Secondary outcome: Proportions of patients who will show improvement in Child Pugh (>2 points)in both groupsProportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups 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 Proportions of patients who will suffer from hepatocellular carcinoma Overall survival in both groups
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Guo-Qing Jiang, MS, Phone: 86-514-87373272, Email: jgqing2003@hotmail.com
Clinical Medical College of Yangzhou University, Yangzhou, Jiangsu 225001, China; Recruiting Luo-Jing Zhou, MD, Phone: 86-514-87373037, Email: luojing76@163.com Dou-Sheng Bai, MD, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: July 29, 2015
|