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Recruiting Not applicable

Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS

NCT07461545 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-04-01
Last updated
2026-03-31

Condition(s) studied

CirrhosisSplenectomyPortal Vein ThrombosisHypertension, Portal

Investigational drug(s) / intervention(s)

Apixaban 2.5 MG →

Apixaban 2.5 MG: If portal vein thrombosis occurs more than one year after laparoscopic splenectomy, 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology. 2. Splenomegaly with secondary hypersplenism. 3. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery. 4. Underwent laparoscopic splenectomy at our center. 5. 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. 6. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3 7. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3. 8. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12. 9. Developed portal vein thrombosis after 12 months post-surgery. 10. 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. Portal hypertension bleeding . 5. Child - Pugh C 6. Recent peptic ulcer disease 7. History of Hemorrhagic stroke 8. Pregnancy. 9. Uncontrolled Hypertension 10. Human immunodeficiency virus (HIV) infection

Primary outcome measure(s)

  • Proportion of complete recanalization of portal vein thrombosis — Follow-up of 6 months or greater
    Proportion of complete recanalization of portal vein thrombosis

Trial sites (1)

FacilityCityRegionStatus
Clinical Medical College Yangzhou Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07461545 on ClinicalTrials.gov ↗ ← All trials in China