NCT05355662

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11,569

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
Last Updated

May 2, 2022

Status Verified

March 1, 2022

Enrollment Period

4 years

First QC Date

March 16, 2022

Last Update Submit

April 27, 2022

Conditions

Keywords

elderly donorliver transplantationdonation after cardiac deathhepatocellular carcinomasurvival

Outcome Measures

Primary Outcomes (3)

  • Post-operative survival time

    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

    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

    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 Outcomes (2)

  • Surgery details

    Intraoperative

  • 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.

Study Arms (3)

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

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

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

Interventions

AgeOTHER

The study was retrospective and did not involve the application of interventions.

ALDsILDsOLDs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Recipient age ≥ 18 years and \< 65 years.
  • Donor age ≥ 18 years.

You may not qualify if:

  • Recipient age \<18 years or ≥65 years.
  • Donor age \<18 years.
  • Patients who died within 30 days after transplantation.
  • Secondary liver transplantation.
  • Multiple organ transplantation.
  • Patients with incomplete data or failed follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Aging

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Bo Wang, MD PhD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2022

First Posted

May 2, 2022

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

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.