Status:
COMPLETED
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Lead Sponsor:
University of Pennsylvania
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
8-18 years
Brief 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...
Detailed 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 un...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01135485
Start Date
March 1 2010
End Date
December 1 2016
Last Update
August 2 2017
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104