Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of complete recanalization of portal vein thrombosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
- •Splenomegaly with secondary hypersplenism.
- •No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
- •Underwent laparoscopic splenectomy at our center.
- •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
- •subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3
- •Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD
- •Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to
- •Developed portal vein thrombosis after 12 months post-surgery.
- •Provided informed consent to participate in the study.
排除标准
- •Hepatocellular carcinoma or any other malignancy.
- •Hypercoagulable state other than the liver disease related.
- •DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- •Portal hypertension bleeding .
- •Child - Pugh C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Uncontrolled Hypertension
- •Human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Apixaban group
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, 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.
干预措施: Apixaban 2.5 MG (Drug)
结局指标
主要结局
Proportion of complete recanalization of portal vein thrombosis
时间窗: Follow-up of 6 months or greater
Proportion of complete recanalization of portal vein thrombosis
次要结局
- Proportion of partial recanalization of portal vein thrombosis(Follow-up of 6 months or greater)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital