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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05355662
Other study ID # No. XJTU1AF-CRF-2019-029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2018

Study information

Verified date March 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11569
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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 Surgery details Detailed information such as operation time Intraoperative
Secondary Post-operative complications in patients who underwent liver transplantation 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.
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