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Completed

NCT Number: NCT02247414

Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection

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 after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  • Splenomegaly with secondary hypersplenism
  • Bleeding portal hypertension
  • INo 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
  • Human immunodeficiency virus (HIV) infection

Treatment and study plan

Warfarin

Drug

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

dipyridamole

Drug

From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.

Other names: Gardoxin, Coribon, Curantyl, Dilaplus

Aspirin

Drug

From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.

Other names: Acenterine, Acetard, Acetophen

Low molecular weight heparin

Drug

From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.

Other names: Fraxiparine

Primary outcomes

  1. Proportions of patients who will suffer 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 outcomes

  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 in both groups

    Time frame: 3 years

  5. Overall survival in both groups

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

Acronym: ESWAPH

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 25, 2014
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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