NCT00929032|Completed
Liver Transplantation and Reticuloendothelial Clearance Capacity
The Impact of Liver Transplantation on Reticuloendothelial Clearance Capacity
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The Impact of Liver Transplantation on Reticuloendothelial Clearance Capacity
Sponsor study identifier
observational
12
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2009
Actual (reported)June 26, 2009
Actual (reported)September 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2010
Actual (reported)August 2010
Actual (reported)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.
7 days
To establish whether there is any correlation between liver cell (hepatocyte) injury and immune cell (Kupffer cell) injury after transplantation.
7 days
To establish the effect of liver transplantation on serum expression of acute phase protein opsonins.
7 days
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of Edinburgh
Edinburgh, Midlothian, EH16 4TJ, United Kingdom
Schindl MJ, Millar AM, Redhead DN, Fearon KC, Ross JA, Dejong CH, Garden OJ, Wigmore SJ. The adaptive response of the reticuloendothelial system to major liver resection in humans. Ann Surg. 2006 Apr;243(4):507-14. doi: 10.1097/01.sla.0000205826.62911.a7.
Medzhitov R, Janeway C Jr. Innate immunity. N Engl J Med. 2000 Aug 3;343(5):338-44. doi: 10.1056/NEJM200008033430506. No abstract available.
Stephen J Wigmore, Prof, MD
University of Edinburgh
First Submitted
June 24, 2009
First Posted
June 26, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
August 2010
Actual (reported)Last Updated
October 20, 2010
Record last verified: 2010-10
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Source: ClinicalTrials.gov.
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