NCT04511507

Brief Summary

Hemoadsorption has been demonstrated to improve liver functional tests in patients with liver failure. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with acute liver failure, on liver functional tests, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

5.6 years

First QC Date

August 11, 2020

Last Update Submit

September 3, 2021

Conditions

Liver Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 30 days mortality

    30 days mortality

    30 days

Study Arms (1)

liver failure

patients diagnosed with acute liver failure or acute on chronic liver failure in accordance with national guidelines who require 3 consecutive sessions of hemoadsorption

Procedure: hemoadsorption

Interventions

hemoadsorptionPROCEDURE

three consecutive sessions of hemoadsorption in patients with liver failure

liver failure

Eligibility Criteria

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

\- patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.

You may qualify if:

  • patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines

You may not qualify if:

  • unsigned informed consent
  • duration of therapy under 12 hours
  • death before the three consecutive sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Dana Tomescu, Prof

    Fundeni Clinical Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 13, 2020

Study Start

February 10, 2016

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)