Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorEuropean Foundation for Study of Chronic Liver Failure

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

1. Male or female subject ≥18 years of age.

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.

Disqualifiers

None

Trial population

Acute or subacute liver failure. Patients with hepatocellular carcinoma Subjects listed for transplantation other than liver or liver-kidney transplant. Subjects with previous liver transplantation. Vulnerable population. Pregnant and/or breastfeeding woman Patients with relevant comorbidities

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observational Protocol

    Other intervention

    The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)

Treatment groups

3,000 Participants
are divided into 3 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention

Trial outcomes

Primary outcomes

1

Survival

survival

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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