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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582087
First Posted: April 20, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose
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.

Condition
Acute and Chronic Hepatic Failure With Developing Coma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • The relationship that exist between a liver undergoing chronic or acute degeneration and hepatic coma. [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples Without DNA
Samples previously collected for diagnostic use which could include blood, urine, bile, cerebral spinal fluid, feces, liver tissue, brain tissue.

Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
GI clinic hospital inpatient stay
Criteria

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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582087


Locations
United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Luca Cicalese, MD The University of Texas Medical Branch
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01582087     History of Changes
Other Study ID Numbers: 12-030
First Submitted: April 18, 2012
First Posted: April 20, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by The University of Texas Medical Branch, Galveston:
acute hepatic failure
chronic hepatic failure
coma

Additional relevant MeSH terms:
Coma
Liver Failure
Liver Diseases
End Stage Liver Disease
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hepatic Insufficiency
Digestive System Diseases