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TRANSPLANTATION (DAIT SACCC)

Study: Alloantibodies in Pediatric Heart Transplantation (CTOT-C-04)

Sponsors: NIH/National Institute of Allergy and Infectious Diseases (NIAID) and National Heart, Lung, and Blood Institute (NHLBI)

Consortium: Clinical Trials in Organ Transplantation in Children (CTOT-C) sponsored by NIAID/DAIT

Prime: Rho 

Project Status: Completed

Project Start and End Dates: February 2011–December 2014

Disease: About 500 pediatric heart transplants are done worldwide every year, according to the Pediatric Heart Transplant Study. Nearly 30% of patients reject the transplant and need to be treated in the first year after their transplant. 

Objective: The CTOT-C-04 observational study evaluated 1-year graft and patient survival outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific crossmatch, which means they have harmful antibodies that will attack foreign tissue, such as a transplanted organ from a living donor. Their outcomes were compared with outcomes in heart transplant recipients who don’t have the harmful antibodies.

Study Information: In this study, 6 U.S.-based study sites and 1 Canadian study site enrolled 290 participants. Rho provided statistical, clinical monitoring, data management, and pharmacovigilance support for the funded studies throughout the setup time frame, 12-month enrollment period, and the follow-up period for analysis and publications.

Results: Pediatric heart transplantation recipients with a positive crossmatch (i.e., they develop antibodies that react against the living donor’s organs and their cells) have 1-year graft and patient survival clinical outcomes comparable to those who don’t have the harmful antibodies at the time of transplant. 
Public Health Impact: Studies such as this one will add to the body of knowledge for pediatric heart transplantation. As a result of our support for this study, 3 manuscripts are currently in journal review.

Services: 

  • Clinical Data Management
  • Biostatistics and Statistical Programming
  • Clinical Operations And Monitoring
  • Product Safety and Pharmacovigilance Services