NCT04037995

Brief Summary

The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis often accompanied by a series of complications. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of liver cirrhosis and end-stage liver disease in China.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Sep 2019Sep 2029

First Submitted

Initial submission to the registry

July 14, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Expected
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 14, 2019

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient died during follow-up

    Death occurred during 3 year

    3 years

Secondary Outcomes (1)

  • Major events occurred during follow-up

    3 years

Interventions

No intervation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population who were diagnosed of acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure or hepatocellular carcinoma (stage III-IV)

You may qualify if:

  • Informed consent of patients.
  • Diagnosis of any of the following diseases: acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure and hepatocellular carcinoma (stage III-IV)

You may not qualify if:

  • HIV antibody positive and AIDS patients
  • Serious psychiatric history, especially depression. Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.
  • Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
  • Patients with other malignant tumors (excluding those cured).
  • Pregnant, lactating women or women of childbearing age who are ready to conceive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HuaShan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (1)

  • GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.

    PMID: 28919116BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Jingwen Ai, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of dpartment of infectious disease

Study Record Dates

First Submitted

July 14, 2019

First Posted

July 30, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion (Estimated)

September 1, 2029

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations