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

Conditions

• Acute-On-Chronic Liver Failure
• Liver Cirrhosis
• Liver Diseases
• Liver Transplant; Complications

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 8, 2021

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

3,000 participants (estimated)

Arms

• Arm: 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 (n=2,000)
• Arm: 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 (n=500)
• Arm: Group 3
  patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation (n=500)

Primary Outcome Measure

Survival [ Time Frame: 1 year ]

Central Contacts

• Anna Bosch
  34 93 227 1400
  [email protected]

Locations (18)

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