Actively Recruiting
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection
Led by Northern Jiangsu People's Hospital · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Apixaban is effective and safe for treating portal vein thrombosis that occurs more than one year after laparoscopic splenectomy and azygoportal disconnection. This study focuses on patients with cirrhosis and portal hypertension who develop this condition well after surgery. The goal is to understand how well Apixaban works in this specific situation to help guide future treatments. Participants who develop portal vein thrombosis more than 12 months after the surgery will take 2.5 mg of Apixaban orally twice daily. The effectiveness of the treatment will be assessed every three months using Doppler ultrasound or contrast-enhanced CT scans. If the treatment proves effective, patients will continue taking Apixaban long-term. Throughout the study, patients will undergo regular imaging to monitor the status of their portal vein thrombosis during treatment and follow-up. The main outcome measured is the proportion of patients who achieve complete recanalization of the portal vein after at least six months of treatment. Partial recanalization is also tracked as a secondary outcome. Participants will be observed for safety and treatment response until the study ends in 2027.
CONDITIONS
Brief Title
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A clinical, radiological, or histologic diagnosis of cirrhosis of any cause
- History of portal hypertension bleeding
- Presence of splenomegaly with secondary hypersplenism
- No portal vein thrombosis detected by ultrasound or angio-CT before surgery
- Underwent laparoscopic splenectomy at the study center
- Received 2.5 mg Apixaban twice daily or 100 mg aspirin once daily for 6 months starting 3 days after surgery
- Received low molecular weight heparin injections for 5 days starting 3 days after surgery
- Took oral dipyridamole 25 mg three times daily for 3 months starting 3 days after surgery
- No imaging evidence of portal vein thrombosis between 6 and 12 months after surgery
- Developed portal vein thrombosis more than 12 months after surgery
- Provided informed consent to participate
You will not qualify if you...
- Presence of hepatocellular carcinoma or any other cancer
- Hypercoagulable states unrelated to liver disease
- Use of oral contraceptives, anticoagulants, or anti-platelet drugs
- Child-Pugh Class C liver disease
- Recent peptic ulcer disease
- History of hemorrhagic stroke
- Pregnancy
- Uncontrolled hypertension
- HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until portal vein thrombosis resolves or as decided by the study team
Participants who develop portal vein thrombosis more than one year after laparoscopic splenectomy and azygoportal disconnection will take apixaban 2.5 mg orally twice daily. The treatment continues as long as it remains effective.
Visits every 3 months for Doppler ultrasound or CT scan evaluation
Trial Site Locations
Total: 1 location
1
Clinical Medical College
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
Research Team
G
Guo-Qing Jiang, MD
D
Dou-Sheng Bai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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