Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anticoagulant-induced Bleeding
  • Liver Cirrhosis
  • Portal Hypertension
  • Thrombosis
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

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 ...

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/INR 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.

Tracking Information

NCT #
NCT04397289
Collaborators
Not Provided
Investigators
Study Director: yingmin yao, PhD the first hospital of xi'an jiaotong university