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

NCT01135485 | Completed

• 1 other identifier: 09-007242
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Primary and Secondary Endpoints

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and adolescents between 8 and 18 years of age

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Robert E Shaddy, M.D.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

US (1)