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ACLF-I: Characterization and Pathogenesis of ACLF

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04975490
Collaborator
(none)
1,000
Enrollment
1
Location
61
Anticipated Duration (Months)
16.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups.

  1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis

  2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets

  3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    SAPIENT = Sepsis ACLF patients
    PROACT = Portal mediators as ACLF Targets
    ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [90 days]

      number of patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Liver cirrhosis
    Exclusion Criteria:

    • extrahepatic and metastatic malignancy,

    • refusal for participation

    • decision of attending phycisian

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Translational Hepatology Frankfurt Hessen Germany 60590

    Sponsors and Collaborators

    • Johann Wolfgang Goethe University Hospital

    Investigators

    • Principal Investigator: Jonel Trebicka, MD, PhD, Goethe University Hospital Frankfurt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonel Trebicka, Principal Investigator and Coordinator, Johann Wolfgang Goethe University Hospital
    ClinicalTrials.gov Identifier:
    NCT04975490
    Other Study ID Numbers:
    • ACLF-Initiative
    First Posted:
    Jul 23, 2021
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Liver Failure
    Hypertension, Portal
    End Stage Liver Disease
    Acute-On-Chronic Liver Failure

    Study Results

    No Results Posted as of Jul 29, 2021