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Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04397289
Acronym
ATASICP
Enrollment
70
Registered
2020-05-21
Start date
2018-02-12
Completion date
2021-03-31
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGHeparin 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

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
thrombosis formation1 year after surgery.The evaluation index is the incidence of PVST

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026