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Recruiting NCT07461545

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

No phase Interventional Cirrhosis Splenectomy Portal Vein Thrombosis Hypertension, Portal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apixaban 2.5 MG.
Who it may be relevant to
Registry conditions: Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Proportion of complete recanalization of portal vein thrombosis [Time frame: Follow-up of 6 months or greater]
Secondary outcome measures (1)
  • Proportion of partial recanalization of portal vein thrombosis [Time frame: Follow-up of 6 months or greater]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Clinical Medical College — Yangzhou

Identifiers

NCT: NCT07461545 · YZUC-017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗