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

• Sponsor: The Affiliated Hospital of Qingdao University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05012501
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neutrophil Extracellular Trap Formation; Portal Vein Thrombosis; Liver Cirrhosis	Diagnostic Test: test NETs markers

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 79 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Analysis of Neutrophil Extracellular Traps in Hypercoagulability and Portal Vein Thrombosis in Liver Cirrhosis Patients
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Qingdao University	Qingdao	Shandong	China

Sponsors and Collaborators

• The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of Qingdao University
• ClinicalTrials.gov Identifier: NCT05012501
• Other Study ID Numbers: QYFYWZLL26363
• First Posted: Aug 19, 2021
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Hospital of Qingdao University: Neutrophil Extracellular Trap Formation; Portal Vein Thrombosis; Hypercoagulability
• Additional relevant MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis; Thrombophilia; Fibrosis

Study Results

No Results Posted as of Aug 19, 2021