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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form to participate in the study. Who Should NOT Join This Trial: 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 weakened immune system virus (HIV) infection Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Apixaban 2.5 MG

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.

Locations (1)

Clinical Medical College
Yangzhou, Jiangsu, China