TEA-ACLF: Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05036031
Collaborator
(none)
500
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A retrospective collection and analysis of the preoperative conditions of patients with LT due to cirrhosis in a single center from January 2015 to June 2020 would be conducted, including epidemiological characteristics, etiology, clinical indicators, and short-term (28 days, 90 days) and long-term (1 year, 3 years) survival after LT.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Liver Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study to Evaluate Different Criterion in Predicting Post-transplant Outcomes
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    EASL-CLIF ACLF patients

    APASL ACLF patients

    Non-ACLF patients

    Outcome Measures

    Primary Outcome Measures

    1. 3 years overall survival [Up to ~3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients underwent liver transplantation for cirrhosis

    • The diagnosis of ACLF followed APASL and EASL-CLIF definition.

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Chair: Qiang Xia, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
    • Principal Investigator: Hao Feng, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05036031
    Other Study ID Numbers:
    • Renji-IIT2021091
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 5, 2021