Impact of Race and Re-Transplantation

This study has been terminated.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00229788
First received: September 13, 2005
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. In addition, adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.


Condition
Orthotopic Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Impact of Race and Re-Transplantation in Childhood: Analysis of Data From the United Network of Organ Sharing

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Study Start Date: March 2005
Detailed Description:

Objective 1: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality.

Objective 2: Adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Methods: We would like to review the United Network for Organ Sharing database. We plan on reviewing database records of heart transplantation subjects <18 years of age from 1987 to 2004. Indications for retransplantation and patient race characteristics will be collected and evaluated. Analysis will be performed using proportional hazards regression controlling for other potential risk factors. The contribution economic disparity, insurance status and HLA mismatching to disparities in outcome will also be explored.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • orthotopic heart transplantation
  • < 18 years of age

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00229788

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: William Mahle, MD Emory University and Children's Healthcare of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00229788     History of Changes
Other Study ID Numbers: 05.018
Study First Received: September 13, 2005
Last Updated: June 12, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
orthotopic heart transplantation

ClinicalTrials.gov processed this record on August 26, 2014