Analysis of Neutrophil Extracellular Traps in Hypercoagulability and Portal Vein Thrombosis in Liver Cirrhosis Patients

Completed

• Conditions: Liver Cirrhosis; Neutrophil Extracellular Trap Formation; Portal Vein Thrombosis
• Interventions: Diagnostic Test: test NETs markers

• Registration Number: NCT05012501
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The aim of this study was to investigate whether NETs markers can enhance procoagulant activity and predict portal vein thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making.So we recruit liver cirrhosis with portal vein thrombosis and without portal vein thrombosis treated at the Affiliated Hospital of Qingdao University and collection of blood samples.

Detailed Description

Seventy-nine patients with benign liver cirrhosis treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 26 patients with portal vein thrombosis and 53 patients without portal vein thrombosis. NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), tissue factor, endotoxin, factor X, TAT complex, and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a statistical difference between the two groups, and regression analysis was performed between NETs markers and tissue factor, endotoxin, factor X, TAT complex, and anti-β2 glycoprotein I to investigate whether there was a correlation. This study without any intervention measures, will not cause harm.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Study First Submitted: 2021-07-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

（1) Clinical diagnosis of liver cirrhosis (2) Clinical diagnosis of portal vein thrombosis

Exclusion Criteria

1. primary or secondary liver malignancy
2. hematologic diseases
3. Bud-Chiah syndrome
4. incomplete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVT group	test NETs markers	（1) Patients with cirrhosis diagnosed in accordance with the 2019 Guidelines for the Diagnosis and Treatment of Cirrhosis;(2) In accordance with the diagnostic criteria of portal vein thrombosis in the 2015 European Society of Hepatology Clinical Practice Guidelines: Hepatic Vascular Diseases. Color ultrasound, CT, MRI, and other imaging studies confirmed the presence of portal vein thrombosis and the specific location of the thrombosis.
without PVT group	test NETs markers	(1) Patients with cirrhosis diagnosed in accordance with the 2019 Guidelines for the Diagnosis and Treatment of Cirrhosis;(2)Color ultrasound, CT, MRI, and other imaging studies confirmed the absence of portal vein thrombosis and the specific location of the thrombosis.

Primary Outcome Measures

Name	Time	Method
Concentration of NETs markers	1 year.	NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), tissue factor, endotoxin, factor X, TAT complex, and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.

Trial Locations

Locations (1)

the Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China