Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229788
Status:
TERMINATED
Last Update Posted:
2007-06-13
First Post:
2005-09-13
Brief Title:
Impact of Race and Re-Transplantation
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Impact of Race and Re-Transplantation in Childhood Analysis of Data From the United Network of Organ Sharing
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None