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TerminatedNCT01582087Updated Jul 25, 2023

Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

An observational study in Acute and Chronic Hepatic Failure With Developing Coma, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by The University of Texas Medical Branch, Galveston · Observational

Why this study was terminated
At the request of the PI, the Collaborating PI left the university
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
11
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.

02

Conditions studied

  • Acute and Chronic Hepatic Failure With Developing Coma

Keywords

  • acute hepatic failure
  • chronic hepatic failure
  • coma
03

In context

Liver Failure, Acute

96 studies on the registry are indexed under Liver Failure, Acute; 20 are open to participants now.

This study's enrollment of 11 is below the median of 112 across 34 observational studies indexed under Liver Failure, Acute.

Browse Liver Failure, Acute studies →

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

GI clinic hospital inpatient stay

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics for chronic or acute hepatic failure will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics that do not have a diagnosis of chronic or acute hepatic failure
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
11 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • acute or chronic hepatic failure

    All patients presenting at University of Texas Medical Branch (UTMB) with acute and chronic hepatic failure and who are developing coma

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What researchers measure

Primary outcomes

  1. The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma.

    Time frame: 8 weeks

07

Study locations

1 site
  • The University of Texas Medical Branch
    Galveston, Texas 77555, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01582087
Responsible party
Sponsor
First posted
Apr 20, 2012
Start date
Feb 2012
Primary completion
Jul 24, 2018
Completion
Jul 24, 2018
Last update
Jul 25, 2023

Study contacts

Luca Cicalese, MD
principal investigator · The University of Texas Medical Branch

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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