Liver Transplantation and Reticuloendothelial Clearance Capacity
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Impact of Liver Transplantation on Reticuloendothelial Clearance Capacity|
- 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 ] [ Designated as safety issue: No ]
- To establish whether there is any correlation between liver cell (hepatocyte) injury and immune cell (Kupffer cell) injury after transplantation. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- To establish the effect of liver transplantation on serum expression of acute phase protein opsonins. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Liver transplant recipient
Liver transplant recipient
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00929032
|University of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH16 4TJ|
|Principal Investigator:||Stephen J Wigmore, Prof, MD||University of Edinburgh|