Impact of Race and Re-Transplantation

Orthotopic Heart Transplantation Clinical Trial

Official title:

Impact of Race and Re-Transplantation in Childhood: Analysis of Data From the United Network of Organ Sharing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229788
• Other study ID #: 05.018
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 12, 2007
• Start date: March 2005

Study information

• Verified date: June 2007
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• orthotopic heart transplantation

• < 18 years of age

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Orthotopic Heart Transplantation

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,