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

NCT02238444 | Unknown Phase 4 DMC

• 1 other identifier: YZUC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hypertension; Venous Thrombosis; Status; Splenectomy

Keywords

Warfarin; Portal Vein; Anticoagulants; Cirrhosis; Hypertension; Venous Thrombosis; Splenectomy

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (5)

• 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

Study Arms (2)

Warfarin with dipyridamole

EXPERIMENTAL

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; Drug: Dipyridamole; Drug: Low Molecular Weight Heparin

Aspirin with dipyridamole

ACTIVE COMPARATOR

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; Drug: Aspirin; Drug: Low Molecular Weight Heparin

Interventions

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.

Also known as: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN

Warfarin with dipyridamole

Dipyridamole DRUG

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

Also known as: Gardoxin, Coribon, Curantyl, Dilaplus

Aspirin with dipyridamole; Warfarin with dipyridamole

Aspirin DRUG

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

Also known as: Acenterine, Acetard, Acetophen

Aspirin with dipyridamole

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.

Also known as: Fraxiparine

Aspirin with dipyridamole; Warfarin with dipyridamole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Conditions

Fibrosis; Hypertension; Venous Thrombosis

Interventions

Warfarin; Dipyridamole; Aspirin; aspirin, magnesium oxide combination; Heparin, Low-Molecular-Weight; Nadroparin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidines; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Dou-Sheng Bai, MD

  Clinical Medical College of Yangzhou University

  STUDY CHAIR

• Guo-Qing Jiang, MS

  Clinical Medical College of Yangzhou University

  STUDY DIRECTOR

• Ping Chen, MD

  Clinical Medical College of Yangzhou University

  PRINCIPAL INVESTIGATOR

• Sheng-Jie Jin

  Clinical Medical College of Yangzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo-Qing Jiang, MS

CONTACT

86-514-87373272; jgqing2003@hotmail.com

Dou-sheng Bai, MD

CONTACT

86-514-87373275; bdsno1@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CN (1)