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

September 1, 2021 updated by: RenJi Hospital

Liver Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study to Evaluate Different Criterion in Predicting Post-transplant Outcomes

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
EASL-CLIF ACLF patients
APASL ACLF patients
Non-ACLF patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 years overall survival
Time Frame: Up to ~3 years
Up to ~3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Hao Feng, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renji-IIT2021091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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