Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460824
Status:
WITHDRAWN
Last Update Posted:
2013-12-31
First Post:
2007-04-16
Brief Title:
A Retrospective Review - Anti-HLA Antibodies
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Retrospective Review of Anti-HLA Antibodies and Donor Crossmatch Results as a Predictor of Pediatric Heart Transplant Outcomes
Status:
WITHDRAWN
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not a Clinical trial Retrospective Data review only
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transplant rejection following organ transplant occurs because the recipients immune system attacks the transplanted organ The recipients immune system recognizes the transplanted organ as foreign tissue and attempts to destroy it in the similar way that it attempts to destroy infectious agents such as bacteria and viruses The human leukocyte antigen HLA system is a set of genes that is responsible for controlling an individuals ability to tell the difference between an infectious agent and self tissue
Differences in HLA genes between donors and recipients play a major part in influencing the rejection or acceptance of foreign tissue ie transplanted organs Due to time limitations in heart transplantation HLA matching is not considered It is unclear how individual HLA differences affect the recovery and expected lifespan of pediatric heart transplant recipients
This study is designed to look at the donor-recipient matching and mismatching to determine if mismatching leads to more complications shorter graft survival and therefore increased risk of death following pediatric heart transplantation
Differences in HLA genes between donors and recipients play a major part in influencing the rejection or acceptance of foreign tissue ie transplanted organs Due to time limitations in heart transplantation HLA matching is not considered It is unclear how individual HLA differences affect the recovery and expected lifespan of pediatric heart transplant recipients
This study is designed to look at the donor-recipient matching and mismatching to determine if mismatching leads to more complications shorter graft survival and therefore increased risk of death following pediatric heart transplantation
Detailed Description:
It is generally thought that immunologic mismatching in solid organ transplant will lead to increased rates of graft failure due to acute rejection in the short term and chronic rejection or coronary vasculopathy in the longterm Many studies in renal pancreas and lung transplantation suggest favorable outcomes when HLA matching occurs and unfavorable outcomes when HLA mismatching occurs and circulating donor-specific antibodies are produced
However in heart transplantation this association is less clear Advances in recognition and identification of HLA antibodies have resulted in more specific information regarding HLA mismatching and outcomes This study is aimed at analyzing outcomes in pediatric heart transplant based on recipient-donor HLA incompatibility and the post-transplant production of donor-specific HLA antibodies
Hypothesis
1 HLA systems genes class I II matching results in a survivalrejection benefit in pediatric heart transplant recipients
2 Mismatched transplants with donor-specific HLA antibodies have decreased overall survival
A Multivariate Analysis of data will be performed by both Emory and Childrens investigators and research support staff
However in heart transplantation this association is less clear Advances in recognition and identification of HLA antibodies have resulted in more specific information regarding HLA mismatching and outcomes This study is aimed at analyzing outcomes in pediatric heart transplant based on recipient-donor HLA incompatibility and the post-transplant production of donor-specific HLA antibodies
Hypothesis
1 HLA systems genes class I II matching results in a survivalrejection benefit in pediatric heart transplant recipients
2 Mismatched transplants with donor-specific HLA antibodies have decreased overall survival
A Multivariate Analysis of data will be performed by both Emory and Childrens investigators and research support staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None