Acute-On-Chronic Liver FailureTEA-ACLFNCT05036031
Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
An observational study of Acute-On-Chronic Liver Failure and Liver Cirrhosis, run by RenJi Hospital.
Trial summary
The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure, Liver Cirrhosis, Liver Transplant; Complications
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Oct 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients underwent liver transplantation for cirrhosis at Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China between January 2015 and June 2020 were considered for inclusion.
Who may be able to join
- patients underwent liver transplantation for cirrhosis
- The diagnosis of ACLF followed APASL and EASL-CLIF definition.
Who cannot join
- Patients with malignant tumor or underwent living donor liver transplantation (LDLT) were excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Liver Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study to Evaluate Different Criterion in Predicting Post-transplant Outcomes
The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.
Read the detailed description
A retrospective collection and analysis of the preoperative conditions of patients with LT due to cirrhosis in a single center from January 2015 to June 2020 would be conducted, including epidemiological characteristics, etiology, clinical indicators, and short-term (28 days, 90 days) and long-term (1 year, 3 years) survival after LT.
- Keywords
- Acute-On-Chronic Liver Failure, EASL-CLIF criteria, APASL criteria
- Medical subject headings
- Acute-On-Chronic Liver Failure, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EASL-CLIF ACLF patients | Not described | |
| APASL ACLF patients | Not described | |
| Non-ACLF patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years overall survival
Measured: Up to ~3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, Study chair, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTUHao Feng, Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036031
- Sponsor's protocol ID
- Renji-IIT2021091
- Acronym
- TEA-ACLF
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study to Evaluate Different Criterion in Predicting Post-transplant Outcomes
- ClinicalTrials.gov ID
- NCT05036031
- Acronym / sponsor ID
- TEA-ACLF / Renji-IIT2021091
- Keywords
- Acute-On-Chronic Liver Failure, EASL-CLIF criteria, APASL criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 5 Sep 2021 (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.
The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.
Detailed description
A retrospective collection and analysis of the preoperative conditions of patients with LT due to cirrhosis in a single center from January 2015 to June 2020 would be conducted, including epidemiological characteristics, etiology, clinical indicators, and short-term (28 days, 90 days) and long-term (1 year, 3 years) survival after LT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EASL-CLIF ACLF patients | – | – |
| APASL ACLF patients | – | – |
| Non-ACLF patients | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent liver transplantation for cirrhosis at Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China between January 2015 and June 2020 were considered for inclusion.
Key inclusion criteria (2 listed)
- patients underwent liver transplantation for cirrhosis
- The diagnosis of ACLF followed APASL and EASL-CLIF definition.
Key exclusion criteria (1 listed)
- Patients with malignant tumor or underwent living donor liver transplantation (LDLT) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3 years overall survival
Time frame: Up to ~3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Qiang Xia study chair
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Hao Feng principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure and Liver Cirrhosis, run by RenJi Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Feng, MD., Ph.D. (008615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 years overall survival (time frame: Up to ~3 years). 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 5 Sep 2021.