Liver TransplantationNCT05355662
Prognosis Analysis of Elderly Donor Liver in Liver Transplantation
An observational study of Liver Transplantation and Hepatocellular Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Hepatocellular Carcinoma, Survival
- What is being tested?
- Age
- How many people
- 11,569 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Recipient age ≥ 18 years and < 65 years.
- Donor age ≥ 18 years.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma, Survival
- Being tested
- Age
- Keywords
- elderly donor, liver transplantation, donation after cardiac death, hepatocellular carcinoma, survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgeOther
The study was retrospective and did not involve the application of interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative survival time
Postoperative survival time for patients receiving liver transplantation
Measured: 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
Measured: 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
Measured: 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
Detailed information such as operation time
Measured: Intraoperative
Post-operative complications in patients who underwent liver transplantation
Specific details of all post-operative complications in patients who underwent liver transplantation
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 11,569 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Bo Wang, MD PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355662
- Sponsor's protocol ID
- No. XJTU1AF-CRF-2019-029
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Analysis of Elderly Donor Liver From Donation After Cardiac Death in Liver Transplantation: a Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05355662
- Acronym / sponsor ID
- No. XJTU1AF-CRF-2019-029
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma, Survival
- Keywords
- elderly donor, liver transplantation, donation after cardiac death, hepatocellular carcinoma, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,569 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OLDs | – | Other: AgeOlder 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. |
| ILDs | – | Other: AgeIdeal 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. |
| ALDs | – | Other: AgeAverage 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Recipient age ≥ 18 years and < 65 years.
- Donor age ≥ 18 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AgeThe study was retrospective and did not involve the application of interventions. | Other | ALDs, ILDs, OLDs |
Primary outcome
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
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
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
2 secondary outcomes
Surgery details
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wang, MD PhD study chair
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Hepatocellular Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.