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NCT05012501 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05012501
Other study ID # QYFYWZLL26363
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 28, 2021

Study information
Verified date August 2021
Source The Affiliated Hospital of Qingdao University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• test NETs markers
NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), tissue factor, endotoxin, factor X, TAT complex, and anti-ß2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.

Locations
Country Name City State
China the Affiliated Hospital of Qingdao University Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of NETs markers NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), tissue factor, endotoxin, factor X, TAT complex, and anti-ß2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. 1 year.
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