Prognosis Analysis of Elderly Donor Liver in Liver Transplantation

April 27, 2022 updated by: Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University

Prognosis Analysis of Elderly Donor Liver From Donation After Cardiac Death in Liver Transplantation: a Multicenter Clinical Study

Based on the follow-up data of elderly donation after cardiac death(DCD) donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the Chinese organ donation system was developed in 2015, donation has been the only source of organs for transplantation in China. Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2018, were retrospectively identified using the CLTR, a database and official website for national data gathering. Based on the follow-up data of elderly DCD donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Study Type

Observational

Enrollment (Actual)

11569

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2018, were retrospectively identified using the CLTR, a database and official website for national data gathering.

Description

Inclusion Criteria:

  1. Recipient age ≥ 18 years and < 65 years.
  2. Donor age ≥ 18 years.

Exclusion Criteria:

  1. Recipient age <18 years or ≥65 years.
  2. Donor age <18 years.
  3. Patients who died within 30 days after transplantation.
  4. Secondary liver transplantation.
  5. Multiple organ transplantation.
  6. Patients with incomplete data or failed follow-up.

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
Intervention / Treatment
OLDs
Older liver donors (OLDs) and recipients were defined as individuals whose donor age was equal to or greater than 60 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.
Other: Age
The study was retrospective and did not involve the application of interventions.
ILDs
Ideal or young liver donors (ILDs) and recipients were defined as donors aged 18-40 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.
Other: Age
The study was retrospective and did not involve the application of interventions.
ALDs
Average liver donors (ALDs) and recipients were defined as donor age 40-59 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.
Other: Age
The study was retrospective and did not involve the application of interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative survival time
Time Frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.
Postoperative survival time for patients receiving liver transplantation
Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.
Transplanted liver status
Time Frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.The functional status of the transplanted liver was recorded during this period.
Postoperative Liver Function in Patients Undergoing Liver Transplantation
Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.The functional status of the transplanted liver was recorded during this period.
Recurrence of the primary disease after surgery
Time Frame: The time period between liver transplantation and the initial examination revealing a recurrence of primary disease, or until the end of follow-up on December 31, 2020.whichever came first, assessed up to 72 months.
Recurrence of primary disease in patients who underwent liver transplantation after surgery
The time period between liver transplantation and the initial examination revealing a recurrence of primary disease, or until the end of follow-up on December 31, 2020.whichever came first, assessed up to 72 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery details
Time Frame: Intraoperative
Detailed information such as operation time
Intraoperative
Post-operative complications in patients who underwent liver transplantation
Time Frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.During this period, all postoperative complications of the patient will be recorded.
Specific details of all post-operative complications in patients who underwent liver transplantation
Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.During this period, all postoperative complications of the patient will be recorded.

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Bo Wang, MD PhD, First Affiliated Hospital Xi'an Jiaotong 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 (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. XJTU1AF-CRF-2019-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study was based on national information from the Chinese Liver Transplant Registry and the investigators did not have access to patient information or raw data.

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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