An official website of the United States government

This repository is under review for potential modification in compliance with Administration directives.
Citation
Anand, Ravinder (2021). Studies of Pediatric Liver Transplantation (SPLIT) (Version 3) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/vgw3-t830
Data Availability Statement
Data from the Studies of Pediatric Liver Transplantation (SPLIT) [(Version 3) https://doi.org/10.58020/vgw3-t830] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The SPLIT study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the SPLIT (https://doi.org/10.58020/vgw3-t830) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the SPLIT study and does not necessarily reflect the opinions or views of the SPLIT study, NIDDK-CR, or NIDDK.
Data Package Version
Version 3 (Updated on: Feb 11, 2021)
Resource Availability
Resource Use Information
Publications
Explore publications resulting from the use of study resources
View publications (0)

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.

Primary 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

Inclusion 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.

Research Area

Endocrine Diseases and Metabolic Diseases, Liver Disease, Digestive Diseases, Multidisciplinary Research

Study Type

Observational

Study Sites

45

Condition

Cholestasis, Fulminant Viral Hepatitis, Progressive Familial Intrahepatic Cholestasis, Hepatoblastoma, Cancer, Tyrosinemia, Budd-Chiari Syndrome, Cystic Fibrosis, Inborn Disorder of Bile Acid Synthesis, Primary Hyperoxaluria, Hepatocellular Carcinoma, Autoimmune Hepatitis, Urea Cycle Disorder, Hepatitis B Virus Infection, Alpha 1-Antitrypsin Deficiency, Hemangioendothelioma, Crigler-Najjar Syndrome, Parenteral Nutrition-Associated Cholestasis, Primary Sclerosing Cholangitis, Fibrotic Liver Disease, Hepatitis C Virus Infection, Hepatitis A Virus Infection, Acute Liver Failure, Wilson Disease, Cirrhosis of Liver, Bile Duct Disorder, Neonatal Hemochromatosis, Glycogen Storage Disease, Isolated Congenital Hepatic Fibrosis, Biliary Atresia, Alagille Syndrome

Medication or Intervention Agent

None

Procedure

None

Keywords

Lymphoproliferative Disease, Transplant Rejection Incidence, Immunosuppressive Therapy, Liver Translantation, Graft Survival, Epstein Barr Virus/Lymphoproliferative Disease (EBV/LPD), Liver Diseases

NIDDK Division

Division of Digestive Diseases and Nutrition (DDN)

There are currently no public documents available