Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection

Not Applicable

Completed

• Conditions: Splenectomy; Venous Thrombosis; Hypertension, Portal; Cirrhosis
• Interventions: Drug: Apixaban 2.5 MG; Drug: Dipyridamole 25Mg Tab; Drug: subcutaneous Low Molecular Weight Heparin

• Registration Number: NCT05304455
• Lead Sponsor: Northern Jiangsu People's Hospital

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Study Start: 2022-04-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apixaban group	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.
Apixaban group	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.
Apixaban group	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis	6 months	Proportion of participants with Main and intrahepatic branches of portal vein thrombosis by ultrasound evaluation

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with Splenic vein thrombosis	6 months	Proportion of participants withSplenic vein thrombosis by ultrasound evaluation
Proportion of participants with Mesenteric vein thrombosis	6 months	Proportion of participants with Mesenteric vein thrombosis by ultrasound evaluation

Trial Locations

Locations (1)

Clinical Medical College, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China