NCT07461532

Brief 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 and azygoportal disconnection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 4, 2026

Last Update Submit

March 25, 2026

Conditions

SplenectomyPortal Vein ThrombosisCirrhosisHypertension, Portal

Keywords

CirrhosisPortal Vein ThrombosisPortal HypertensionApixabanSplenectomyLaparoscopyHypersplenismAzygoportal disconnection

Outcome Measures

Primary Outcomes (1)

  • Proportion of complete recanalization of portal vein thrombosis

    Proportion of complete recanalization of portal vein thrombosis

    Follow-up of 6 months or greater

Secondary Outcomes (1)

  • Proportion of partial recanalization of portal vein thrombosis

    Follow-up of 6 months or greater

Study Arms (1)

Apixaban group

EXPERIMENTAL

If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, 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

Interventions

Apixaban 2.5 MGDRUG

If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, 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.

Apixaban group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Conditions

FibrosisHypertension, PortalHypersplenism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesSplenic DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Dou-Sheng Bai

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373272jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373275bdsno1@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)