Clinical trial NCT05355662: Prognosis Analysis of Elderly Donor Liver in Liver Transplantation
Official title: Prognosis Analysis of Elderly Donor Liver From Donation After Cardiac Death in Liver Transplantation: a Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Hepatocellular Carcinoma
Survival
Keywords: elderly donor
liver transplantation
donation after cardiac death
hepatocellular carcinoma
survival
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 11569
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative survival time
timeFrame: 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.
measure: Transplanted liver status
timeFrame: 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.
measure: Recurrence of the primary disease after surgery
timeFrame: 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:
measure: Surgery details
timeFrame: Intraoperative
measure: Post-operative complications in patients who underwent liver transplantation
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Bo Wang, MD PhD
role: STUDY_CHAIR
References: