Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

Liver Cirrhosis Clinical Trial

— ATASICP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397289
• Other study ID #: XJTU1AF2017LSK-43
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 12, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Thrombosis

Intervention

Drug:
• Heparin and Rivaroxaban
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

Locations

Country	Name	City	State
China	the first hospital of xi'an jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombosis formation	The evaluation index is the incidence of PVST	1 year after surgery.