Recruiting
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.
ClinicalTrials.gov IDNCT07461532
PhaseNA
Enrollment20
SponsorNorthern Jiangsu People's Hospital
Age18 Years
SexALL
Conditions studied
Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal
About this study
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.
Interventions
- Drug: Apixaban 2.5 MG — If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.
Primary outcomes
- Proportion of complete recanalization of portal vein thrombosis (Follow-up of 6 months or greater)
Eligibility information
Inclusion Criteria:
1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
2. Portal hypertension bleeding .
3. Splenomegaly with secondary hypersplenism.
4. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
5. Underwent laparoscopic splenectomy at our center.
6. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.
7. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3
8. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.
9. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.
10. Developed portal vein thrombosis after 12 months post-surgery.
11. Provided informed consent to participate in the study.
Exclusion Criteria:
1. Hepatocellular carcinoma or any other malignancy.
2. Hypercoagulable state other than the liver disease related.
3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
4. Child - Pugh C
5. Recent peptic ulcer disease
6. History of Hemorrhagic stroke
7. Pregnancy.
8. Uncontrolled Hypertension
9. Human immunodeficiency virus (HIV) infection
Study locations
- Clinical Medical College, Yangzhou, Jiangsu 225001 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.