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

1 augustus 2017 bijgewerkt door: University of Pennsylvania

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Aangeboren hartafwijkingen

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Pennsylvania
  - Philadelphia, Pennsylvania, Verenigde Staten, 19104
    - The Children's Hospital of Philadelphia

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Children and adolescents between 8 and 18 years of age

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Primary and Secondary Endpoints Tijdsspanne: 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.	2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Onderzoekers

Hoofdonderzoeker: Robert E Shaddy, M.D., Children's Hospital of Philadelphia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2010

Primaire voltooiing (Werkelijk)

1 december 2016

Studie voltooiing (Werkelijk)

1 december 2016

Studieregistratiedata

Eerst ingediend

1 juni 2010

Eerst ingediend dat voldeed aan de QC-criteria