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

1. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

33

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • The Children's Hospital of Philadelphia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Children and adolescents between 8 and 18 years of age

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary and Secondary Endpoints
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Robert E Shaddy, M.D., Children's Hospital of Philadelphia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2010

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

1. juni 2010

Først indsendt, der opfyldte QC-kriterier

1. juni 2010

Først opslået (Skøn)

2. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09-007242

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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