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Trial record 23 of 581 for:    bilirubin AND liver function

HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification (HERCOLE)

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ClinicalTrials.gov Identifier: NCT03312036
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriele Donati, St. Orsola Hospital

Brief Summary:
CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.

Condition or disease Intervention/treatment Phase
Liver Failure, Acute Liver Failure, Acute on Chronic Device: Coupled plasma filtration and adsorption (CPFA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification
Actual Study Start Date : June 6, 2013
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Arm Intervention/treatment
Experimental: CPFA Patients
Patients affected by acute or acute on chronic liver failure who undergo Coupled plasma filtration and adsorption (CPFA) to recover their basal liver function or as a bridge to liver transplantation. The intervention is CPFA treatment which lasts 6 hour length. The intervention can be repeated for a maximum of 5 times.
Device: Coupled plasma filtration and adsorption (CPFA)
Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a "bridge" to liver transplantation




Primary Outcome Measures :
  1. The mortality reduction of patients with acute or acute on chronic liver failure; [ Time Frame: 1 year ]
    The measure is the overall survival of the patients after CPFA and standard medical therapy


Secondary Outcome Measures :
  1. Efficacy of liver toxins detoxification [ Time Frame: 1 year. ]
    The measures of efficacy consist in the evaluation bilirubin levels, biliary acids levels, ammonia levels and lactate levels

  2. Improvement of hepatic encephalopathy [ Time Frame: 1 year ]
    The measure of hepatic encephalopathy is assessed by means of the West Haven Criteria

  3. Improvement of the arterial blood pressure of the patients [ Time Frame: 1 year ]
    Measuring arterial blood pressure (mmHg) on starting CPFA, during the CPFA treatment and at CPFA end.

  4. Biocompatibility of CPFA [ Time Frame: 1 year ]
    Blood leukocytes, platelets, Hemoglobin are assessed before and after each CPFA treatment

  5. Cytokines clearance during CPFA [ Time Frame: 1 year ]
    Interleukin-6, Tumor Necrosis Factor alfa, Interleukin-10, Hepatocyte growth factor are assessed before and after each CPFA treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute liver failure
  • Acute on chronic liver failure
  • Bridge to liver transplantation

Exclusion Criteria:

  • acute hemorrhage
  • shock
  • respiratory failure
  • acute coronary syndrome
  • psychiatric illnesses

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): NCT03312036


Locations
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Italy
Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital
Bologna, Italy
Sponsors and Collaborators
St. Orsola Hospital
Investigators
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Principal Investigator: Gaetano La Manna, Prof. University of Bologna

Publications:

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Responsible Party: Gabriele Donati, M.D. PhD, St. Orsola Hospital
ClinicalTrials.gov Identifier: NCT03312036     History of Changes
Other Study ID Numbers: 87/2012/O/Disp
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriele Donati, St. Orsola Hospital:
CPFA
Liver failure
Resin
detoxification

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases