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NCT00486057 Clinical Trial

Daclizumab Experience in Pediatric Heart Transplant

Congenital Disorders Clinical Trial

Official title:
A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00486057
Other study ID # 06-199
Secondary ID
Status Terminated
Phase N/A
First received June 12, 2007
Last updated November 18, 2011
Start date August 2004
Est. completion date November 2007

Study information
Verified date November 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Status post heart transplant

- Age 0-21 years

- Received Daclizumab as induction therapy

Exclusion Criteria:

- Those who do not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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, 

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