NCT00460824

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1988

Completed
18.8 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

First QC Date

April 16, 2007

Last Update Submit

December 29, 2013

Conditions

Keywords

transplantHLA antibodies matchingimmunologic mismatching

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • subjects undergoing retransplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert Bray, PhD

    Emory University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 17, 2007

Study Start

July 1, 1988

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations