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Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy (ESWA)

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ClinicalTrials.gov Identifier: NCT02238444
Recruitment Status : Recruiting
First Posted : September 12, 2014
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Guo-Qing Jiang, Yangzhou University

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Hypertension Venous Thrombosis Status; Splenectomy Drug: Warfarin Drug: Dipyridamole Drug: Aspirin Drug: Low Molecular Weight Heparin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy
Study Start Date : September 1, 2014
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Experimental: Warfarin with dipyridamole
From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus.
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.
Other Names:
  • Warfarin Sodium
  • Athrombine
  • COUMADIN
  • PANAWARFIN

Drug: Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
  • Gardoxin
  • Coribon
  • Curantyl
  • Dilaplus

Drug: 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.
Other Name: Fraxiparine

Active Comparator: Aspirin with dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year.
Drug: Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
  • Gardoxin
  • Coribon
  • Curantyl
  • Dilaplus

Drug: Aspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
Other Names:
  • Acenterine
  • Acetard
  • Acetophen

Drug: 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.
Other Name: Fraxiparine




Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups [ Time Frame: 3 years ]
  2. Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups [ Time Frame: 3 years ]
  3. 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 [ Time Frame: 3 years ]
  4. Proportions of patients who will suffer from hepatocellular carcinoma [ Time Frame: 3 years ]
  5. Overall survival in both groups [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238444


Contacts
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Contact: Guo-Qing Jiang, MS 86-514-87373272 jgqing2003@hotmail.com
Contact: Dou-sheng Bai, MD 86-514-87373275 bdsno1@hotmail.com

Locations
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China, Jiangsu
Clinical Medical College of Yangzhou University Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Luo-Jing Zhou, MD    86-514-87373037    luojing76@163.com   
Principal Investigator: Dou-Sheng Bai, MD         
Sponsors and Collaborators
Yangzhou University
Investigators
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Study Chair: Dou-Sheng Bai, MD Clinical Medical College of Yangzhou University
Study Director: Guo-Qing Jiang, MS Clinical Medical College of Yangzhou University
Principal Investigator: Ping Chen, MD Clinical Medical College of Yangzhou University
Principal Investigator: Sheng-Jie Jin Clinical Medical College of Yangzhou University

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Responsible Party: Guo-Qing Jiang, Master, Yangzhou University
ClinicalTrials.gov Identifier: NCT02238444     History of Changes
Other Study ID Numbers: YZUC-001
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

Keywords provided by Guo-Qing Jiang, Yangzhou University:
Warfarin
Portal Vein
Anticoagulants
Cirrhosis
Hypertension
Venous Thrombosis
Splenectomy

Additional relevant MeSH terms:
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Anticoagulants
Hypertension
Fibrosis
Thrombosis
Venous Thrombosis
Hypersplenism
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Splenic Diseases
Lymphatic Diseases
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Dipyridamole
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action