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| Sponsor: | Children's Healthcare of Atlanta |
|---|---|
| Information provided by: | Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT00229788 |
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: | Natural History, Longitudinal, Defined Population, Retrospective Study |
| Official Title: | Impact of Race and Re-Transplantation in Childhood: Analysis of Data From the United Network of Organ Sharing |
| Study Start Date: | March 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| United States, Georgia | |
| Children's Healthcare of Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | William Mahle, MD | Emory University and Children's Healthcare of Atlanta |
More Information
| Study ID Numbers: | 05.018 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00229788 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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orthotopic heart transplantation |