Actively Recruiting
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy
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
This research aims to evaluate whether Apixaban is effective and safe for treating portal vein thrombosis that occurs more than one year after laparoscopic splenectomy in patients with cirrhosis and related conditions. The study focuses on patients who have undergone this surgery and later develop this specific type of thrombosis. The purpose is to understand how well Apixaban works in this situation and to monitor its effects on the thrombosis. Participants who develop portal vein thrombosis more than a year after their laparoscopic splenectomy will receive oral Apixaban at a dose of 2.5 mg twice daily. The response to this treatment will be assessed every three months using Doppler ultrasound or contrast-enhanced CT scans to check changes in the thrombosis. If the treatment is found to be effective, patients will continue taking Apixaban. During the study, patients will attend regular imaging assessments to monitor changes in their portal vein thrombosis. The main outcome being measured is the proportion of patients who achieve complete reopening (recanalization) of the thrombosed portal vein after six months or more of treatment. Partial recanalization rates will also be tracked as a secondary outcome. Participants will be followed throughout this period to assess treatment outcomes and safety, with the study expected to run until 2027.
CONDITIONS
Brief Title
Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Clinical, radiological, or histologic diagnosis of cirrhosis of any cause
- Splenomegaly with secondary hypersplenism
- No portal vein thrombosis by ultrasound and angio-CT before surgery
- Underwent laparoscopic splenectomy at the study center
- Received oral Apixaban 2.5 mg twice daily or aspirin 100 mg once daily for 6 months starting on postoperative day 3
- Received low molecular weight heparin injections for 5 days starting on postoperative day 3
- Received oral dipyridamole 25 mg three times daily for 3 months starting on postoperative day 3
- No imaging evidence of portal vein thrombosis during months 6 to 12 post-surgery
- Developed portal vein thrombosis more than 12 months after surgery
- Provided informed consent to participate
You will not qualify if you...
- Hepatocellular carcinoma or any other cancer
- Hypercoagulable state unrelated to liver disease
- Use of oral contraceptives, anticoagulants, or anti-platelet drugs
- Portal hypertension bleeding
- 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 - At least 6 months
Participants receive oral apixaban 2.5 mg twice daily to treat portal vein thrombosis occurring more than one year after laparoscopic splenectomy. The efficacy of apixaban is monitored using Doppler ultrasound or contrast-enhanced CT scans every three months.
Visits every 3 months for imaging assessments
Trial Site Locations
Total: 1 location
1
Clinical Medical College
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
Research Team
G
Guo-Qing Jiang
D
Dou-Sheng Bai
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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