An interventional study of Apixaban 2.5 MG and Dipyridamole 25Mg Tab in Cirrhosis, Splenectomy and Venous Thrombosis, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Prevention
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
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.
332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 206 interventional studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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 MG · Drug: Dipyridamole 25Mg Tab · 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.
Also known as: ELIQUIS
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
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
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
Time frame: 6 months
Proportion of participants with Splenic vein thrombosis
Proportion of participants withSplenic vein thrombosis by ultrasound evaluation
Time frame: 6 months
Proportion of participants with Mesenteric vein thrombosis
Proportion of participants with Mesenteric vein thrombosis by ultrasound evaluation
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital