Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01135485
First received: June 1, 2010
Last updated: October 13, 2014
Last verified: October 2014

June 1, 2010
October 13, 2014
March 2010
July 2012   (final data collection date for primary outcome measure)
Primary and Secondary Endpoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary objective is to determin 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.
Same as current
Complete list of historical versions of study NCT01135485 on ClinicalTrials.gov Archive Site
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Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Children and adolescents between 8 and 18 years of age

Congenital Heart Disease
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  • 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.
  • Control Group
    The control group who have undergone palliative or corrective surgery for congenital heart disease during infancy (<1 year of age) not requiring allograft material.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
August 2015
July 2012   (final data collection date for primary outcome measure)

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)
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01135485
09-007242
No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Robert E Shaddy, M.D. Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP