Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 8 - 18 |
Updated: | 8/3/2017 |
Start Date: | March 2010 |
End Date: | December 2016 |
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.
with HLHS and related lesions who have undergone stage I palliation during infancy using an
allograft patch demonstrate continued evidence of HLA antibody formation.
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.
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.
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)
We found this trial at
1
site
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials