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

NCT05012501 | Completed

• 1 other identifier: QYFYWZLL26363
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutrophil Extracellular Trap Formation; Portal Vein Thrombosis; Liver Cirrhosis

Keywords

Neutrophil Extracellular Trap Formation; Portal Vein Thrombosis; Hypercoagulability

Outcome Measures

Primary Outcomes (1)

• Concentration of NETs markers

  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.

  1 year.

Study Arms (2)

PVT group

（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.

Diagnostic Test: test NETs markers

without PVT group

(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.

Diagnostic Test: test NETs markers

Interventions

test NETs markers DIAGNOSTIC_TEST

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.

PVT group; without PVT group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• primary or secondary liver malignancy
• hematologic diseases
• Bud-Chiah syndrome
• incomplete data

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Biospecimen

Retention: NONE RETAINED

Plasm

MeSH Terms

Conditions

Liver Cirrhosis; Thrombophilia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)