Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection

Cirrhosis Clinical Trial

— ESAPT  

Official title:

Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304455
• Other study ID #: YZUC-009
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2023
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Hypertension, Portal
• Splenectomy
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants with Splenic vein thrombosis	Proportion of participants withSplenic vein thrombosis by ultrasound evaluation	6 months
Secondary	Proportion of participants with Mesenteric vein thrombosis	Proportion of participants with Mesenteric vein thrombosis by ultrasound evaluation	6 months