NCT00486057

Daclizumab Experience in Pediatric Heart Transplant

A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Children's Healthcare of Atlanta · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation. Literature suggests that the time to first rejection episode can be avoided or delayed by using induction therapy.

Detailed description

In August 2005 the heart transplant team at Children's Healthcare of Atlanta began a protocol of Daclizumab 1mg/kg IV every two weeks for 5 doses; 1st dose to be received in the operating room following discontinuation of cardiopulmonary bypass. Since one year has passed following initiation of this practice, it is necessary to review this immuno-suppression strategy and determine if, in fact, there was clinical benefit of reducing rejection without increasing the vulnerabilities of the immuno-compromised host. We wish to review all heart transplant recipient records between August 1, 2004 and October 15, 2006. Historically, Children's has done approximately 10 transplants per year; therefore, we will review approximately 15 charts at Children's Healthcare of Atlanta and Sibley Heart Center Cardiology.

Conditions

• Congenital Disorders

Timeline

• Start date: 2004-08-01
• Completion: 2007-11-01
• First posted: 2007-06-13
• Last updated: 2011-11-21

Locations

1 site across 1 country: United States