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OpenTrials
Completed

NCT Number: NCT01135485

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2010
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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