NCT05304455

Brief Summary

The purpose of this study is to determine whether Apixaban is effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

March 19, 2022

Last Update Submit

December 15, 2023

Conditions

CirrhosisSplenectomyVenous ThrombosisHypertension, Portal

Keywords

CirrhosisVenous thrombosisPortal HypertensionApixabanSplenectomyLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis

    Proportion of participants with Main and intrahepatic branches of portal vein thrombosis by ultrasound evaluation

    6 months

Secondary Outcomes (2)

  • Proportion of participants with Splenic vein thrombosis

    6 months

  • Proportion of participants with Mesenteric vein thrombosis

    6 months

Study Arms (1)

Apixaban group

EXPERIMENTAL

From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.

Drug: Apixaban 2.5 MGDrug: Dipyridamole 25Mg TabDrug: subcutaneous Low Molecular Weight Heparin

Interventions

Apixaban 2.5 MGDRUG

From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.

Also known as: ELIQUIS
Apixaban group
Dipyridamole 25Mg TabDRUG

From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.

Also known as: Persantine
Apixaban group
subcutaneous Low Molecular Weight HeparinDRUG

From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.

Also known as: LMWHs
Apixaban group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  • Splenomegaly with secondary hypersplenism
  • Bleeding portal hypertension
  • 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.
  • Child - Pugh C
  • Recent peptic ulcer disease
  • History of Hemorrhagic stroke
  • Pregnancy.
  • Uncontrolled Hypertension
  • Human immunodeficiency virus (HIV) infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

FibrosisVenous ThrombosisHypertension, Portal

Interventions

apixabanDipyridamole

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ping Chen, MD

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 31, 2022

Study Start

April 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)