Characterization and Pathogenesis of ACLF

NCT ID: NCT04975490

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Acute-On-Chronic Liver Failure Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SAPIENT = Sepsis ACLF patients

No interventions assigned to this group

PROACT = Portal mediators as ACLF Targets

No interventions assigned to this group

ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis

Exclusion Criteria

* extrahepatic and metastatic malignancy,
* refusal for participation
* decision of attending phycisian
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonel Trebicka

Principal Investigator and Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonel Trebicka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Goethe University Hospital Frankfurt

Locations

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Translational Hepatology

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jonel Trebicka, MD, PhD

Role: CONTACT

+4963014256

Facility Contacts

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Jonel Trebicka

Role: primary

Other Identifiers

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ACLF-Initiative

Identifier Type: -

Identifier Source: org_study_id

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