Clinical trial NCT01135485: Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Official title: Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents between 8 and 18 years of age

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 demonstrate continued evidence of HLA antibody formation.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary and Secondary Endpoints
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Robert E Shaddy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: