The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- thrombosis formation
研究概览
简要总结
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
-
) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
-
) Liver cirrhosis complicated with liver tumor;
-
) Liver cirrhosis complicated with blood system diseases;
-
) Patients who have not signed the informed consent form.
-
Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
-
) Heparin group
-
) Rivaroxaban group
-
) Control group.
详细描述
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
-
) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
-
) Liver cirrhosis complicated with liver tumor;
-
) Liver cirrhosis complicated with blood system diseases;
-
) Patients who have not signed the informed consent form.
-
Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
-
) Heparin group: Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT（prothrombin time）/INR（international normalized ratio） was kept at 1.25-1.5.
-
) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
-
) Control group: No preventive intervention measures. If platelets in the above groups are > 500× 109/L, aspirin 100 mg qd is added for 1 month. If platelets are > 1000× 109/L, platelet collection is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension
排除标准
- •Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
- •Liver cirrhosis complicated with liver tumor;
- •Liver cirrhosis complicated with blood system diseases;
- •Patients who have not signed the informed consent form.
研究组 & 干预措施
Heparin group
Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT/INR was kept at 1.25-1.5.
干预措施: Heparin and Rivaroxaban (Drug)
Rivaroxaban group
Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
干预措施: Heparin and Rivaroxaban (Drug)
Control group
No preventive intervention measures.
干预措施: Heparin and Rivaroxaban (Drug)
结局指标
主要结局
thrombosis formation
时间窗: 1 year after surgery.
The evaluation index is the incidence of PVST
次要结局
未报告次要终点