Apixaban for portal vein thrombosis occurring more than one year after laparoscopic splenectomy and azygoportal disconnection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol gives oral apixaban 2.5 mg twice daily to patients who develop portal vein thrombosis more than 12 months after laparoscopic splenectomy and azygoportal disconnection. Efficacy and clot status are monitored every three months using Doppler ultrasound or contrast-enhanced CT. Patients who show improvement on imaging continue apixaban, while safety monitoring focuses on bleeding and liver-related adverse events. Eligible participants are those operated on at the enrolling center who had no thrombosis in the first postoperative year and consent to serial imaging follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Medical College
  Yangzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Guo-Qing Jiang, MD
• Email: jgqing2003@hotmail.com
• Phone: +8651487373272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.