Identification and Verification of Neutrophil Extracellul... | NCT05909319

Studies
Identification and Verification of Neutrophil Extracellular Trap Net Related Markers in Acute-on-chronic Liver Failure

NCT05909319

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute-On-Chronic Liver Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2023Estimated

Primary Completion Date

Dec 25, 2024Estimated

Completion Date

Jun 25, 2025Estimated

First Submitted Date

May 29, 2023

First Submission Date that Met QC Criteria

Jun 11, 2023

First Posted Date

Jun 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute-on-chronic liver failure (ACLF) refers to the acute deterioration of liver function in patients with chronic liver disease. Neutrophils are a major component of the innate immune system, and previous studies have revealed enhanced production of neutrophil extracellular traps (NETs) in ACLF. However, there is still a lack of systematic research on the correlation between NETs and the prognosis of ACLF. We screened NETs related biomarkers through bioinformatics analysis, which play an important role in the diagnosis of ACLF. This study will explore whether these NETs related biomarkers also play an important role in the prognosis of ACLF and further investigate their role in the pathogenesis of ACLF.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
ACLF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	mortality of patients with ACLF	30 days
mortality	mortality of patients with ACLF	90 days
mortality	mortality of patients with ACLF	half a year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patients who meet the diagnostic criteria of Chinese Group on the Study of Severe Hepatitis B (COSSH) for acute-on-chronic liver failure

Exclusion Criteria:

Age greater than 75 years old
liver cancer
previous liver transplantation
other serious extrahepatic organ diseases
uncontrolled bacterial infections.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who meet the diagnostic criteria of Chinese Group on the Study of Severe Hepatitis B (COSSH) for acute-on-chronic liver failure

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D065290	Acute-On-Chronic Liver Failure

Ancestor Terms

ID	Term
D017114	Liver Failure, Acute
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided