Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy(ESAWAAPT)
NCT04645550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-03-21
Summary
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
Conditions
- Cirrhosis
- Splenectomy; Status
- Venous Thrombosis
- Hypertension, Portal
Interventions
- DRUG
-
Apixaban
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
- DRUG
-
Warfarin
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.
- DRUG
-
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
- DRUG
-
Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
- DRUG
-
Low molecular weight heparin
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Sponsors & Collaborators
-
Northern Jiangsu People's Hospital
lead OTHER
Principal Investigators
-
Dou-Sheng Bai Bai, MD · Clinical Medical College of Yangzhou University
-
Guo-Qing Jiang, MD · Clinical Medical College of Yangzhou University
-
Sheng-Jie Jin, MD · Clinical Medical College of Yangzhou University
-
Bao-Huan Zhou, MS · Clinical Medical College of Yangzhou University
-
Tian-Ming Gao, MS · Clinical Medical College of Yangzhou University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-22
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- China
Study Locations
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