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

NCT07461532 — Not applicable, Recruiting, 20 participants, Northern Jiangsu People's Hospital

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

RegistryNCT07461532
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Estimated)
SponsorNorthern Jiangsu People's Hospital (Other)
ConditionsCirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal
InterventionsApixaban 2.5 MG (Drug)
Datesstart 2026-04-01 (estimated), primary completion 2027-09-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-03-10, last updated 2026-03-31
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Cirrhosis All trials for Splenectomy All trials of Apixaban 2.5 MG

-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.

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+Detailed description

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

+Arms and interventions

ArmTypeInterventionsDescription
Apixaban groupExperimentalDrug: Apixaban 2.5 MGIf 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 2.5 MG (Drug): 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.

+Outcome measures

Primary outcomes

  • Proportion of complete recanalization of portal vein thrombosis [Follow-up of 6 months or greater]: Proportion of complete recanalization of portal vein thrombosis

Secondary outcomes

  • Proportion of partial recanalization of portal vein thrombosis [Follow-up of 6 months or greater]: Proportion of partial recanalization of portal vein thrombosis

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Clinical Medical CollegeYangzhou, JiangsuChinaRecruiting

+Investigators

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