Graft Injury Markers in Children Post Solid Organ Transplant
Research type
Research Study
Full title
A prospective study of markers, including Donor Specific Antibodies (DSA) for graft injury in children following solid organ transplantation
IRAS ID
245991
Contact name
Girish Gupte
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS FT
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
The outcome of any solid organ transplant (i.e. kidney, liver, intestine, heart etc.) can be adversely affected by the development of rejection and other insults resulting in injury known as graft hepatitis, fibrosis and cirrhosis. Rejection is a process whereby the transplanted tissue is attacked by the body’s own immune system. Other forms of injury can be caused in a variety of ways, i.e infections; non-compliance with medication to prevent rejection; other medication. Rejection and injury can lead to the transplanted organ not working well; loss of transplanted organ requiring transplantation or death.
In solid organ transplantation (SOT) , there are two types of rejection cellular rejection and antibody mediated rejection. The diagnostic criteria and treatment of acute cellular rejection are well established. Antibody mediated rejection has recently been recognised to contribute to acute as well as long term chronic graft damage in kidney and heart transplant.
Until recently it was thought that the liver transplant patients are not affected by antibody mediated rejection. Recent case reports and adult cases have suggested that antibody mediated rejection does occur in the liver transplant population and can adversely affect long term outcome.
The studies done so far are retrospective studies i.e. on stored samples from tissue banks and hence difficult to draw a definite conclusion to the role of antibody mediated rejection. This study will aim to fill our gaps of knowledge of antibody mediated rejection in the liver and SOT population and give us insight to its effect on acute rejection and long term chronic graft damage.
Other studies looking at molecular and genetic markers will provide further insight on other causes of graft injury and their effect on long term graft function.
This will improve the long term outcomes following SOT and will keep the graft stable for a number of years.
Informed consent will be obtained from children undergoing transplant assessment over the next two years; children already on the transplant list; post-transplant children undergoing protocol biopsy or undergoing biopsy for deranged liver function tests (LFTs)
The blood tests necessary for detecting antibodies, molecular and genetic markers will be drawn at the time of other blood tests involved in the clinical care of the patient and hence will not involve extra visits to Birmingham Women’s and Children’s Hospital or additional blood tests. These blood tests cannot currently be requested as a part of normal post solid organ transplant (SOT) follow-up as the role of these antibodies and other markers and their effect on rejection and long term graft injury is not well established
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0293
Date of REC Opinion
4 Nov 2019
REC opinion
Further Information Favourable Opinion