Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
Recruiting · NCT07461532 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Apixaban 2.5 MG
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
- Portal hypertension bleeding .
- Splenomegaly with secondary hypersplenism.
- No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
- Underwent laparoscopic splenectomy at our center.
- 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.
- subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3
- Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.
- Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.
- Developed portal vein thrombosis after 12 months post-surgery.
- Provided informed consent to participate in the study.
Exclusion criteria
- Hepatocellular carcinoma or any other malignancy.
- Hypercoagulable state other than the liver disease related.
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Child - Pugh C
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
- Pregnancy.
- Uncontrolled Hypertension
- Human immunodeficiency virus (HIV) infection
Where it is running
1 location listed.
- Clinical Medical College - Yangzhou, Jiangsu, China