COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease (BANDED)

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. Identifier: NCT01701687
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : August 3, 2015
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.

Condition or disease
Alcoholic Liver Diseases Decompensated Cirrhosis

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
Study Start Date : September 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Decompensated Alcoholic Cirrhosis
Recruited patients will have diagnosed liver cirrhosis (histological, radiological or accepted clinical parameters)admitted with an episode of decompensation. Patients must still be drinking hazardous alcohol quantities (>14 units for women, >21 units for men) at study enrollment

Primary Outcome Measures :
  1. Liver Related Death [ Time Frame: 6 months ]
    The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis

Secondary Outcome Measures :
  1. Non-Liver related death [ Time Frame: 6 months ]
    Mortality unrelated to liver disease up to 6 months from baseline study visit

  2. Hospital Readmission [ Time Frame: 6 months ]
    Hospital readmission secondary to complications of cirrhosis

  3. Alcohol abstinence [ Time Frame: 6 months ]
    Proportion of patients abstinent from alcohol at the 6 month timepoint

Biospecimen Retention:   Samples Without DNA
Serum, plasma and urine stored at -80 degrees centigrade under written patient consent

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potentially eligible patients are adult patients with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation. 100 patients will be recruited for baseline visit over an 30 month study enrolment period, with a 6 month follow up period for all patients.

Inclusion Criteria:

  • Male or female patients 18-75 years of age
  • Diagnosis of cirrhosis based upon:

    • a) Histological confirmation
    • b) Combination of clinical and radiological criteria
    • c) Validated non invasive biomarker
  • Alcohol as the primary aetiology for liver cirrhosis
  • Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
  • Active alcohol drinking prior to index hospital admission

Exclusion Criteria:

  • Grade 3 or 4 hepatic encephalopathy
  • Hepatocellular carcinoma
  • Active non hepatic malignancy
  • Known complete portal vein thrombosis
  • Alcohol abstinence at time of index hospital admission
  • Pregnancy
  • Active cardiac devices (e.g. cardiac pacemaker, implantable cardioverter defibrillator)

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 identifier (NCT number): NCT01701687

Layout table for location information
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Notts, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Layout table for investigator information
Principal Investigator: Neil Guha, MRCP, PhD University of Nottingham
Layout table for additonal information
Responsible Party: University of Nottingham Identifier: NCT01701687    
Other Study ID Numbers: 12050
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by University of Nottingham:
Alcoholic liver disease
Decompensated liver cirrhosis
Hazardous alcohol
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Liver Diseases
Liver Diseases, Alcoholic
Pathologic Processes
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders