Anticoagulation Therapy After Splenectomy in Cirrhosis Patient (ATASICP)

Xi'an Jiaotong University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Portal Hypertension; Thrombosis; Liver Cirrhosis; Anticoagulant-induced Bleeding

Treatments: Drug: Heparin and Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT04397289

XJTU1AF2017LSK-43

Details and patient eligibility

About

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:

1. ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;

2. ) Liver cirrhosis complicated with liver tumor;

3. ) Liver cirrhosis complicated with blood system diseases;

4. ) Patients who have not signed the informed consent form.

5. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

6. ) Heparin group

7. ) Rivaroxaban group

8. ) Control group.

Full 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:

1. ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;

2. ) Liver cirrhosis complicated with liver tumor;

3. ) Liver cirrhosis complicated with blood system diseases;

4. ) Patients who have not signed the informed consent form.

5. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

6. ) 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.

7. ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.

8. ) 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.

9. 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Heparin group

Experimental group

Description:

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.

Treatment:

Drug: Heparin and Rivaroxaban

Rivaroxaban group

Experimental group

Description:

Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.

Treatment:

Drug: Heparin and Rivaroxaban

Control group

Sham Comparator group

Description:

No preventive intervention measures.

Treatment:

Drug: Heparin and Rivaroxaban