Apixaban for portal vein clots that appear more than a year after laparoscopic splenectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with cirrhosis who had laparoscopic splenectomy at the center and who develop portal vein thrombosis more than 12 months after surgery will receive oral apixaban 2.5 mg twice daily. Treatment response will be monitored every three months using Doppler ultrasound or contrast-enhanced CT scans, and patients who show clot resolution or improvement will continue apixaban. Eligible participants previously had perioperative prophylaxis and no imaging evidence of thrombosis during months 6–12 postoperatively. Safety monitoring for bleeding and liver-related events will be performed during follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Medical College
  Yangzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Guo-Qing Jiang
• Email: jgqing2003@hotmail.com
• Phone: +8651487373382

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vagus nerve–guided laparoscopic spleen removal with azygoportal disconnection

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• Education to prevent infections after spleen removal

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• Comparing blood thinners for people with cirrhosis and portal vein clots

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  Recruiting Phase 4 Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07132515

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.