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Impact of Race and Re-Transplantation

NCT ID: NCT00229788

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Orthotopic Heart Transplantation

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* orthotopic heart transplantation
* \< 18 years of age

Exclusion Criteria

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Principal Investigators

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William Mahle, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University and Children's Healthcare of Atlanta

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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05.018

Identifier Type: -

Identifier Source: org_study_id