NCT05036031

Brief Summary

The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

September 1, 2021

Last Update Submit

September 1, 2021

Conditions

Acute-On-Chronic Liver FailureLiver CirrhosisLiver Transplant; Complications

Keywords

Acute-On-Chronic Liver FailureEASL-CLIF criteriaAPASL criteria

Outcome Measures

Primary Outcomes (1)

  • 3 years overall survival

    Up to ~3 years

Study Arms (3)

EASL-CLIF ACLF patients

APASL ACLF patients

Non-ACLF patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients underwent liver transplantation for cirrhosis at Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China between January 2015 and June 2020 were considered for inclusion.

You may qualify if:

  • patients underwent liver transplantation for cirrhosis
  • The diagnosis of ACLF followed APASL and EASL-CLIF definition.

You may not qualify if:

  • Patients with malignant tumor or underwent living donor liver transplantation (LDLT) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qiang Xia

    Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

    STUDY CHAIR

  • Hao Feng

    Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Feng, MD., Ph.D.

CONTACT

008615000901110surgeonfeng@live.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 5, 2021

Study Start

September 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09