RecruitingRecruiting
Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS
NCT07461545 · Northern Jiangsu People's Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy
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.
Eligibility criteria
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 design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-01
Estimated completion: 2027-09-30
Last updated: 2026-03-31
Interventions
Drug: Apixaban 2.5 MG
Primary outcomes
- • Proportion of complete recanalization of portal vein thrombosis (Follow-up of 6 months or greater)
Sponsor
Northern Jiangsu People's Hospital · other
Contacts & investigators
ContactGuo-Qing Jiang · contact · jgqing2003@hotmail.com · +8651487373382
ContactDou-Sheng Bai · contact · bdsno1@hotmail.com · +8651487373382
InvestigatorDou-Sheng Bai · study_chair, Clinical Medical College, Yangzhou University
All locations (1)
Clinical Medical CollegeRecruiting
Yangzhou, Jiangsu, China