Daclizumab Experience in Pediatric Heart Transplant

This study has been terminated.
(sufficient data collected for conclusion of retrospective study)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00486057
First received: June 12, 2007
Last updated: November 18, 2011
Last verified: November 2007
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 30
Study Start Date: August 2004
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Those who do not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486057

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Kirk R Kanter, MD Children's Healthcare of Atlanta, Pediatric Surgery
  More Information

No publications provided

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00486057     History of Changes
Other Study ID Numbers: 06-199
Study First Received: June 12, 2007
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
Daclizumab
Immuno-suppression protocol
Heart Transplant
Rejection

Additional relevant MeSH terms:
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014