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Liver Transplantation and Reticuloendothelial Clearance Capacity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929032
First Posted: June 26, 2009
Last Update Posted: October 20, 2010
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.
Collaborators:
NHS Lothian
European Society of Organ Transplantation
Information provided by:
University of Edinburgh
  Purpose

Study summary: "Liver transplantation and the reticuloendothelial clearance capacity."

The purpose of this study is to evaluate the effect of liver transplantation on the immune system.

This study will involve the taking of a number of observations but does not involve any treatment, which differs from normal care. Indications for transplantation are solely based on the best clinical practice, which is usually performed at the department.

The study measures liver function based on the clearance of different "marker" substances by the liver. These substances are given intravenously and their clearance will be measured from bloodstream.

All substances used in this study are registered in the United Kingdom for clinical applications and already used in clinical practice over years. They are safe and without any risk to harm individuals under study. Furthermore no side effects or any symptoms caused by the administration of these substances are expected.

Measurements of liver function are undertaken before transplantation, 1 and 7 days following the transplant. There is no restriction from any of the patient's prescribed medication. All blood samples will be removed from the cannula (drip) and will not require repeated injections. It is hoped that this research will lead to a greater understanding of the effects of liver transplantation on the immune system.


Condition Intervention
Hepatic Insufficiency Liver Insufficiency Radiation: Nanocoll®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Liver Transplantation on Reticuloendothelial Clearance Capacity

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • We want to establish the immediate particulate clearance capacity of the liver following transplantation and the pattern of recovery one week later. This is used as a surrogate for liver clearance of bacteria and bacterial products. [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • To establish whether there is any correlation between liver cell (hepatocyte) injury and immune cell (Kupffer cell) injury after transplantation. [ Time Frame: 7 days ]
  • To establish the effect of liver transplantation on serum expression of acute phase protein opsonins. [ Time Frame: 7 days ]

Estimated Enrollment: 12
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver transplant recipient
Liver transplant recipient
Radiation: Nanocoll®
To determine reticuloendothelial system (RES) phagocytosis activity and liver phagocytic function respectively we will measure plasma clearance of 99mTc labelled micro-aggregated human albumin without any imaging studies.

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on the waiting list for liver transplantation will be invited to participate in the study and written informed consent will be obtained from each participant. Patients who are undergoing transplantation will be studied before operation, 24 hours after transplantation and 7 days after transplantation.
Criteria

Inclusion Criteria:

  • written informed consent
  • chronic liver disease
  • listed for transplantation at the Scottish Liver Transplant Unit

Exclusion Criteria:

  • pregnancy (although pregnant patients would not be listed for liver transplant)
  • prisoners
  • acute liver failure
  • living-related liver transplantation
  • multi-organ transplantation or re-transplantation
  • ABO incompatible donor
  • HIV-positive donor or recipient
  • not given informed consent
  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): NCT00929032


Locations
United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4TJ
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
European Society of Organ Transplantation
Investigators
Principal Investigator: Stephen J Wigmore, Prof, MD University of Edinburgh
  More Information

Publications:
Responsible Party: The Queen´s Medical Research Institute, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00929032     History of Changes
Other Study ID Numbers: NanospheresLiverEdinburgh09
First Submitted: June 24, 2009
First Posted: June 26, 2009
Last Update Posted: October 20, 2010
Last Verified: October 2010

Keywords provided by University of Edinburgh:
Liver Transplantation
Immunosystem of the Liver
Marginal and Non-marginal grafts

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics