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

Completed

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT01135485

Run by

University of Pennsylvania

People needed

33

Starts

2010-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-08-02

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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