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NCT Number: NCT07461545

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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, the efficacy of apixaban in treating portal vein thrombosis will be examined every three months using Doppler ultrasound screening or contrast-enhanced CT scans. If it is effective, the patient will continue to take apixaban.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
  • 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.
  • Portal hypertension bleeding .
  • Child - Pugh C
  • Recent peptic ulcer disease
  • History of Hemorrhagic stroke
  • Pregnancy.
  • Uncontrolled Hypertension
  • Human immunodeficiency virus (HIV) infection

Treatment and study plan

Apixaban 2.5 MG

Drug

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.

Primary outcomes

  1. Proportion of complete recanalization of portal vein thrombosis

    Time frame: Follow-up of 6 months or greater

    Proportion of complete recanalization of portal vein thrombosis

Secondary outcomes

  1. Proportion of partial recanalization of portal vein thrombosis

    Time frame: Follow-up of 6 months or greater

    Proportion of partial recanalization of portal vein thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai

CONTACT

[email protected]

+8651487373382

Guo-Qing Jiang

CONTACT

[email protected]

+8651487373382

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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