Chance Study

What is the Purpose of this Study?

Primary: To compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT with patients with decompensated cirrhosis without ACLF-2 or 3 at the time of LT and transplant-free survival of patients with ACLF-2 or 3 not listed for LT. Secondary objectives are as follows: - To assess the proportion of patients with ACLF-2 or 3 referred to transplant team who are listed or not and reasons of this decision. - To evaluate the outcomes of patients listed with ACLF-2 or 3 on the waiting list compared with those of patients listed with decompensated cirrhosis without ACLF-2 or 3. - To define independent predictive factors of death/delisting on the waiting list for patients listed with ACLF-2 or 3 and develop a new prognostic model based on ACLF criteria to predict mortality on the waiting list and to improve the allocation of organs. - To compare the characteristics of accepted grafts for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3 and their impact on post-LT outcomes. - To explore independent predictive factors of death after LT for patients transplanted with ACLF-2 or 3 to design futility criteria for LT. - To compare post-LT survival rates of patients with ACLF-2 or 3 at listing and patients without ACLF at listing who develop ACLF-2 or 3 on the waiting list. - To compare post-LT quality of life (QoL) for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3. - To assess the resources utilization for patients listed with ACLF-2 or 3 (in intention-to-treat and per protocol) compared with patients listed with decompensated cirrhosis without ACLF-2 or 3 The exploratory objectives are as follows: - To assess the predictive ability of new biomarkers to predict the prognosis on the waiting list and after LT for patients with decompensated cirrhosis with or without ACLF-2 or 3. - To investigate the impact of LT on systemic disturbances (inflammation, leukocyte dysfunction, metabolic alterations) observed in ACLF. - To explore the mechanisms of liver and extrahepatic organ recovery after LT in patients with ACLF-2 or 3 and determinants of this recovery


Eligibility

  • * 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).
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Liver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure : iNdications and outComEs Study

Study Details
Disease Type/Condition

Other

Principal Investigator

Kuo, Alexander

Co-Investigators

Juvelyn Palomique, Nicholas Nissen

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001254

ClinicalTrials.gov ID

NCT04613921

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Kuo, Alexander

Age Group

Adult

Phase

N/A

IRB Number

CHANCE

ClinicalTrials.gov ID

NCT04613921

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org