NCT04613921 Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
| NCT ID | NCT04613921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Foundation for Study of Chronic Liver Failure |
| Condition | Liver Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2021-07-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2021-07-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
Eligibility Criteria
Inclusion Criteria: * 1\. Male or female subject ≥18 years of age. 2\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology). 3\. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team: * Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list. * Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD\>20) at the time of listing. * Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation. 4\. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04613921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613921 currently recruiting?
Yes, NCT04613921 is actively recruiting participants. Contact the research team at anna.bosch@efclif.com for enrollment information.
Where is the NCT04613921 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Tampa, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT04613921 clinical trial?
NCT04613921 is sponsored by European Foundation for Study of Chronic Liver Failure. The trial plans to enroll 3,000 participants.