Clinical trial NCT04397289: Anticoagulation Therapy After Splenectomy in Cirrhosis Patient
Official title: The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Portal Hypertension
Anticoagulant-induced Bleeding
Thrombosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

1. ) Heparin group
2. ) Rivaroxaban group
3. ) Control group.

Detailed 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.

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

1. ) 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.
2. ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
3. ) 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.

Eligibility 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 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.

Primary outcomes:
measure: thrombosis formation
timeFrame: 1 year after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the first hospital of xi'an jiaotong University
state: Shaanxi
Study officials:
affiliation: the first hospital of xi'an jiaotong university
name: yingmin yao, PhD
role: STUDY_DIRECTOR
References: