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Daclizumab Experience in Pediatric Heart Transplant

A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00486057
Enrollment
30
Registered
2007-06-13
Start date
2004-08-31
Completion date
2007-11-30
Last updated
2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disorders

Keywords

Daclizumab, Immuno-suppression protocol, Heart Transplant, Rejection

Brief 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.

Interventions

None listed

Sponsors

Children's Healthcare of Atlanta
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

* Status post heart transplant * Age 0-21 years * Received Daclizumab as induction therapy

Exclusion criteria

* Those who do not meet inclusion criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026