Studies of Pediatric Liver Transplantation (SPLIT)

General Description

Although liver transplantation is the standard of care therapy for life-threatening liver diseases, the majority of data on the long-term impact of liver transplantation in children have been limited to single-center experiences. The Studies of Pediatric Liver Transplantation (SPLIT) study was designed as a multicenter, observational study to collect prospective data on pediatric patients receiving liver transplantation. Established in 1995, the study aims to characterize and follow trends in patient and graft survival, rejection incidence, growth parameters, and immunosuppressive therapy. Additional study objectives include identifying potential risk factors for patient morbidity and mortality and graft survival.

Patients under 18 years of age who are scheduled for liver transplantation are enrolled at 45 clinical centers. Participants are followed every 6 months for 2 years, and then yearly from the time of listing to transplant. Following transplant, enrolled patients are followed every 6 months for 2 years, and then yearly thereafter until they reach 18 years of age. Data are collected on demographics, primary diagnosis, pretransplant conditions and morbidity, surgical data, and perioperative and long-term morbidity (such as lymphoproliferative disease, rejection, retransplantation, and death).

The data collected in the SPLIT database have been used for various analyses regarding long-term outcomes and risk factors of pediatric liver transplantation. The SPLIT study is ongoing.

While the original SPLIT pediatric registry began in 1995, the NIDDK became the sponsor of SPLIT starting in 2004. Only data collected since 2004, during the time NIDDK sponsored the study, are included in the repository.

Objectives

The primary objectives of the SPLIT study include characterizing and following trends in patient and graft survival, rejection incidence, growth parameters, and immunosuppressive therapy and identifying potential risk factors for patient morbidity and mortality and graft survival.

Outcome Measure

Lymphoproliferative disease; Rejection- Re-transplant; EBV/LPD (Epstein Barr Virus/Lymphoproliferative Disease

Criteria

Eligibility criteria for participants includes:

• Patients under 18 years of age who are currently listed or who are being considered for liver transplantation
• Patients who receive a liver transplant prior to reaching 18 years of age
• Patients who have not previously received any organ transplant other than liver or kidney
• Informed consent and data authorization

Outcome

The data collected in the SPLIT database have been used for various analyses regarding long-term outcomes and risk factors of pediatric liver transplantation. The SPLIT study is ongoing.