Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

Congenital Heart Disease Clinical Trial

Official title:

Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135485
• Other study ID #: 09-007242
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: August 1, 2017
• Start date: March 2010
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether children and adolescents 8-18 years of age with HLHS and related lesions who have undergone stage I palliation during infancy using an allograft patch demonstrate continued evidence of HLA antibody formation.

Description:

This study will be of a prospective cross-sectional design, consisting of three groups. The first two groups (study groups) will consist of (1) subjects with HLHS and other related lesions who have undergone stage I palliation using an allograft patch during infancy and (2) subjects with "single ventricle" lesions who have undergone stage II palliation using allograft without antecedent stage I palliation. The third group (control group) will consist of subjects who have undergone corrective or palliative surgery for CHD during infancy in which an allograft patch was not used, and in which there have been no further exposures to allograft. We have chosen to study both (1) subjects who have undergone stage I and II palliation and (2)subjects who have undergone stage II palliation only in an attempt to distinguish between sensitization that may occur from allograft exposure during stage I palliation and that which may occur during stage II palliation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children and adolescents between 8 and 18 years of age.

• Parents/guardian permission (informed consent)

• Assent of the study subject

• Subjects followed within the CHOP Cardiology Division

• Operative note(s) available for review in medical record

• Have undergone stage I, stage II palliation, or corrective surgery for congenital heart disease during infancy (<1 year of age) not requiring allograft material.

Exclusion Criteria:

• Refusal or withdrawal of informed consent and/or assent.

• unavailability of medical records to confirm operative details.

• Additional surgeries (e.g., other than stage I or II palliation) utilizing allograft

• Exposure to allograft at any point in control group AGE <8 or >18 years

• Presence of genetic syndrome known to affect immunologic function (e.g., DiGeorge syndrome)

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases
• Hypoplastic Left Heart Syndrome

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary and Secondary Endpoints	The primary objective is to determine PRA in a cross-sectional analysis of children and adolescents who have undergone stage I palliation for HLHS and related lesions during infancy, and comparing PRA measurements in a similarly aged group of children and adolescents who have undergone congenital heart surgery during infancy without use of allograft.	2 years