Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Leā¦ (NCT01135485) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
United States33 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range8 Years ā 18 Years
SexALL
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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)