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

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

This trial tests whether taking apixaban twice daily can treat portal vein blood clots that develop more than a year after laparoscopic splenectomy in people with cirrhosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07461545 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People with cirrhosis who underwent laparoscopic splenectomy at the enrolling center, had no postoperative portal vein thrombosis in months 6–12, and then developed portal vein thrombosis more than 12 months after surgery are ideal candidates.

Not a fit: Patients with high bleeding risk, advanced liver failure, active hepatocellular carcinoma, or those who developed portal vein thrombosis within the first year after surgery may not benefit from this protocol.

Why it matters

Potential benefit: If successful, apixaban could offer an effective oral treatment to clear or control portal vein thrombosis that appears late after splenectomy, potentially reducing clot-related complications.

How similar studies have performed: Small studies and case series of direct oral anticoagulants, including apixaban, have shown promise for portal vein thrombosis in cirrhosis, but larger controlled data are still limited.

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

Where this trial is running

Yangzhou, Jiangsu

• Clinical Medical College — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Guo-Qing Jiang

Conditions Cirrhosis; Splenectomy; Portal Vein Thrombosis; Hypertension, Portal; Portal Hypertension; Apixaban; Laparoscopy