Cirrhosis, Splenectomy, Venous Thrombosis, Hypertension, Portal
Conditions
Keywords
Cirrhosis, Venous thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy
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.
Interventions
DRUGApixaban 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.
DRUGDipyridamole 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.
DRUGsubcutaneous 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.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed