Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001, China
NCT Number: NCT04645550
The purpose of this study is to determine whether Apixaban, Warfarin and Aspirin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Yangzhou, Jiangsu, 225001, China
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into apixaban, warfarin or aspirin group. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, patients in warfarin group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months, patients in aspirin group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months. All groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every three months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. 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 in the three groups as per the primary or secondary outcome.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
Other names: ELIQUIS
From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months.
Other names: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
Other names: Acenterine, Acetard, Acetophen
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other names: Gardoxin, Coribon, Curantyl, Dilaplus
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other names: Fraxiparine
Time frame: Two years
Time frame: Two years
Time frame: Two years
Time frame: Two years
Time frame: Two years
Time frame: Two years
Northern Jiangsu People's Hospital
Other
Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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