CTRI/2022/06/042973Recruiting未知
iver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE) Study on behalf of the EASL-CLIF Consortium - CHANCE STUDY
EASLCLIF Consortium0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
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
- •A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study.
- •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:
- •oSubjects 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).
- •oSubjects with severe (grade IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
- •oSubjects with chronic kidney disease requiring hemodialysis
- •oSubjects with severe heart disease (NYHA class III and IV)
- •oSubjects with a known infection with human immunodeficiency virus (HIV)
- •oSubjects 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.
Investigators
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