A Retrospective Review - Anti-HLA Antibodies

This study has been withdrawn prior to enrollment.
(Not a Clinical trial. Retrospective Data review only.)
Sponsor:
Information provided by (Responsible Party):
Robert Bray, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00460824
First received: April 16, 2007
Last updated: December 29, 2013
Last verified: December 2013
  Purpose

Transplant rejection following organ transplant occurs because the recipient's 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 (i.e. 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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Review of Anti-HLA Antibodies and Donor Crossmatch Results as a Predictor of Pediatric Heart Transplant Outcomes

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 0
Study Start Date: July 1988
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 survival/rejection 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 Children's investigators and research support staff.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • heart transplants at Childrens Healthcare of Atlanta, Egleston Hospital
  • transplants between July 1, 1988 through and including January 31, 2007
  • complete HLA data
  • survived more than 30 days after transplant
Criteria

Inclusion Criteria:

  • heart transplants at Childrens Healthcare of Atlanta, Egleston Hospital
  • transplants between July 1, 1988 through and including January 31, 2007
  • complete HLA data
  • survived more than 30 days after transplant

Exclusion Criteria:

  • subjects undergoing retransplant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460824

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Robert Bray, PhD Emory University
  More Information

No publications provided

Responsible Party: Robert Bray, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00460824     History of Changes
Other Study ID Numbers: IRB00003541
Study First Received: April 16, 2007
Last Updated: December 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
transplant
HLA antibodies matching
immunologic mismatching

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014