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

March 25, 2026 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Clinical Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apixaban group
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Follow-up of 6 months or greater

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Follow-up of 6 months or greater

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

  • Study Chair: Dou-Sheng Bai, Clinical Medical College, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUC-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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