NCT04975490

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. 1.SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4.8 years

First QC Date

July 14, 2021

Last Update Submit

July 23, 2021

Conditions

Liver CirrhosisAcute-On-Chronic Liver FailurePortal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mortality

    number of patients

    90 days

Study Arms (3)

SAPIENT = Sepsis ACLF patients

PROACT = Portal mediators as ACLF Targets

ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with liver cirrhosis and complications

You may qualify if:

  • Liver cirrhosis

You may not qualify if:

  • extrahepatic and metastatic malignancy,
  • refusal for participation
  • decision of attending phycisian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Hepatology

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisAcute-On-Chronic Liver FailureHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver Failure, AcuteLiver FailureHepatic Insufficiency

Study Officials

  • Jonel Trebicka, MD, PhD

    Goethe University Hospital Frankfurt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonel Trebicka, MD, PhD

CONTACT

+4963014256jonel.trebicka@kgu.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Coordinator

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 23, 2021

Study Start

December 1, 2020

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(1)