Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
|ClinicalTrials.gov Identifier: NCT01135485|
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : August 2, 2017
|Condition or disease|
|Congenital Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome|
|Study Start Date :||March 2010|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
Study group I
Study group I will include children who have undergone stage I palliation employing allograft material for left ventricular outflow tract reconstruction at CHOP during infancy (<1 year of age). Stage I palliation is defined as an operation in which augmentation of the native ascending aorta and aortic arch is performed to bypass atresia or critical obstruction of the left heart structures.
Study Group II
Study group II who have undergone stage II palliation in which allograft material is used, but have not undergone antecedent stage I palliation. Stage II palliation is defined as a superior cavopulmonary anastomosis in which the superior vena cava is anastomosed to the ipsilateral pulmonary artery via either the bidirectional Glenn or hemi-Fontan procedures.
The control group who have undergone palliative or corrective surgery for congenital heart disease during infancy (<1 year of age) not requiring allograft material.
- Primary and Secondary Endpoints [ Time Frame: 2 years ]The primary objective is to determine PRA in a cross-sectional analysis of children and adolescents who have undergone stage I palliation for HLHS and related lesions during infancy, and comparing PRA measurements in a similarly aged group of children and adolescents who have undergone congenital heart surgery during infancy without use of allograft.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135485
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Robert E Shaddy, M.D.||Children's Hospital of Philadelphia|