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Alloantibodies in Pediatric Heart Transplantation

NCT01005316 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2017-04-20

Study results available
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Summary

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.

Conditions

  • Pediatric Heart Transplantation
  • Pediatric Heart Transplant Recipients

Interventions

DRUG

Induction Therapy

Per standard of care guidelines for immunosuppression at each clinical site.

DRUG

Tacrolimus

Per standard of care guidelines for immunosuppression at each clinical site.

DRUG

Mycophenolate Mofetil

Per standard of care guidelines for immunosuppression at each clinical site.

PROCEDURE

Intraoperative plasma exchange/pheresis

Per standard of care guidelines for immunosuppression at each clinical site.

PROCEDURE

Short-term post-operative plasmapheresis

Per standard of care guidelines for immunosuppression at each clinical site.

DRUG

Immunoglobulins, Intravenous

Post-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site.

DRUG

Prednisone

Maintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stephen A. Webber, MBChB, MRCP · University of Pittsburgh

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005316 on ClinicalTrials.gov