Clinical trial NCT02238444: Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
Official title: Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Hypertension
Venous Thrombosis
Status; Splenectomy
Keywords: Warfarin
Portal Vein
Anticoagulants
Cirrhosis
Hypertension
Venous Thrombosis
Splenectomy
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups
timeFrame: 3 years
measure: Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Proportions of patients who will suffer from hepatocellular carcinoma
timeFrame: 3 years
measure: Overall survival in both groups
timeFrame: 3 years
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College of Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College of Yangzhou University
name: Dou-Sheng Bai, MD
role: STUDY_CHAIR
affiliation: Clinical Medical College of Yangzhou University
name: Guo-Qing Jiang, MS
role: STUDY_DIRECTOR
affiliation: Clinical Medical College of Yangzhou University
name: Ping Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Medical College of Yangzhou University
name: Sheng-Jie Jin
role: PRINCIPAL_INVESTIGATOR
References: