Alloantibodies in Pediatric Heart Transplantation

Stopped early

Conditions studied: Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients

In brief

The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized heart transplant recipients.

Key facts

Study ID

NCT01005316

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

290

Starts

2010-01-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-20

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All participants listed for heart transplantation at participating CTOT-C study sites.

You may not qualify if…

• Listed for multiple organ transplant
• Inability or unwillingness of the participant or parent/guardian to give written informed consent or comply with the study protocol
• Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete at least one year of follow-up
• Current participation in other research studies that would, or might, interfere with the scientific integrity or safety of current study (e.g. by interference with immunosuppression management guidelines, study endpoints, excessive blood draws or SAE evaluation).

Where it is running

• Children's Hospital Boston, Harvard Medical School — Boston, Massachusetts, United States
• St. Louis Children's Hospital, Washington University — St Louis, Missouri, United States
• Children's Hospital of New York, Columbia University Medical Center — New York, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States
• Children's Hospital of Philadelphia, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Hospital for Sick Children, Labatt Family Heart Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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