iver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE)

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 105

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:
o 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.
o 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.
o 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

Exclusion Criteria

1. Acute or subacute liver failure without underlying cirrhosis.
2. Patients with hepatocellular carcinoma outside Milan criteria or other
active neoplasia.
3. Subjects listed for transplantation other than liver or liver-kidney
transplant.
4. Subjects with previous liver transplantation.
5. Vulnerable population (person under temporary or permanent guardianship or
deprived of liberty by a judicial decision).
6. Pregnant and/or breastfeeding woman
7. Patients with relevant comorbidities that could impact the prognosis:
o Subjects with very severe hepatopulmonary syndrome (with PaO2 < 50
mmHg on FiO2 21%) or moderate to severe portopulmonary
hypertension (non-reversible mPAP >= 35 mmHg or PVR >= 500
dyn.s.cm-5).
o Subjects with severe (grade IV) pulmonary disease (Global Obstructive
Lung Disease [GOLD]).
o Subjects with chronic kidney disease requiring hemodialysis
o Subjects with severe heart disease (NYHA class III and IV)
o Subjects with a known infection with human immunodeficiency virus
(HIV)
o Subjects with severe neurological or psychiatric disorders
8. Patients who cannot provide prior informed consent and when there is
documented evidence that the patient has no legal surrogate decision
maker and it appears unlikely that the patient will regain
consciousness or sufficient ability to provide delayed informed consent.
9. Physician and team not committed to provide intensive care if needed.