A Phase 4 interventional study of Warfarin and Dipyridamole in Cirrhosis, Hypertension and Status;Splenectomy, sponsored by Yangzhou University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Yangzhou University · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 124 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus.
Drug: Warfarin · Drug: Dipyridamole · Drug: Low Molecular Weight Heparin
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year.
Drug: Dipyridamole · Drug: Aspirin · Drug: Low Molecular Weight Heparin
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 1 year.
Also known as: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Also known as: Gardoxin, Coribon, Curantyl, Dilaplus
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
Also known as: Acenterine, Acetard, Acetophen
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Also known as: Fraxiparine
Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization
Time frame: 3 years
Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups
Time frame: 3 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
Time frame: 3 years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection
Time frame: 3 years
Proportions of patients who will suffer from hepatocellular carcinoma in both groups
Time frame: 3 years
Overall survival in both groups
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Yangzhou University