Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

Study Overview
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Brief Summary
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1. 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. 2. 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.

Detailed Description
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1. 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. 2. 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. 3. Monitoring indicators Color Doppler ultrasound was reexamined 1, 2, 3 and 4 weeks after operation to find out whether PVST was present. Abdominal CT was performed when PVST was suspected. After the patient's condition is stable, the portal vein system ultrasound is reviewed monthly, and the follow-up time is 1 year.

Official Title
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The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension

Conditions
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Liver Cirrhosis, Portal Hypertension, Anticoagulant-induced Bleeding, Thrombosis

Intervention / Treatment
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* Drug: Heparin and Rivaroxaban


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin group<br>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. | Drug: Heparin and Rivaroxaban<br>* Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation<br>* Other names: platelet collection;|
| Experimental: Rivaroxaban group<br>Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5. | Drug: Heparin and Rivaroxaban<br>* Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation<br>* Other names: platelet collection;|
| Sham Comparator: Control group<br>No preventive intervention measures. | Drug: Heparin and Rivaroxaban<br>* Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation<br>* Other names: platelet collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombosis formation | The evaluation index is the incidence of PVST | 1 year after surgery. |