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Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection

NCT ID: NCT05304455

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-05-31

Brief Summary

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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

Detailed Description

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After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. The Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (POD) 7, at postoperative months (POM) 1, 3, and 6. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done as per the primary outcome.

Conditions

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Cirrhosis Splenectomy Venous Thrombosis Hypertension, Portal

Keywords

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Cirrhosis Venous thrombosis Portal Hypertension Apixaban Splenectomy Laparoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Apixaban group

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.

Group Type EXPERIMENTAL

Apixaban 2.5 MG

Intervention Type DRUG

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.

Dipyridamole 25Mg Tab

Intervention Type DRUG

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.

subcutaneous Low Molecular Weight Heparin

Intervention Type DRUG

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.

Interventions

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Apixaban 2.5 MG

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.

Intervention Type DRUG

Dipyridamole 25Mg Tab

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.

Intervention Type DRUG

subcutaneous Low Molecular Weight Heparin

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.

Intervention Type DRUG

Other Intervention Names

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ELIQUIS Persantine LMWHs

Eligibility Criteria

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Inclusion Criteria

1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
2. Splenomegaly with secondary hypersplenism
3. Bleeding portal hypertension
4. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
5. Informed consent to participate in the study

Exclusion Criteria

1. Hepatocellular carcinoma or any other malignancy,
2. Hypercoagulable state other than the liver disease related
3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
4. Child - Pugh C
5. Recent peptic ulcer disease
6. History of Hemorrhagic stroke
7. Pregnancy.
8. Uncontrolled Hypertension
9. Human immunodeficiency virus (HIV) infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Jiangsu People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo-Qing Jiang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Chen, MD

Role: STUDY_CHAIR

Clinical Medical College, Yangzhou University

Locations

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Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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YZUC-009

Identifier Type: -

Identifier Source: org_study_id