An official website of the United States government
- Data Available for Request
- Specimens Not Available
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.
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.
Lymphoproliferative disease; Rejection- Re-transplant; EBV/LPD (Epstein Barr Virus/Lymphoproliferative Disease
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
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.
Liver Disease, Digestive Diseases, Multidisciplinary Research, Endocrine Diseases and Metabolic Diseases
Observational
45
Wilson Disease, Fibrotic Liver Disease, Fulminant Viral Hepatitis, Cirrhosis of Liver, Hemangioendothelioma, Progressive Familial Intrahepatic Cholestasis, Parenteral Nutrition-Associated Cholestasis, Cancer, Crigler-Najjar Syndrome, Alagille Syndrome, Cystic Fibrosis, Primary Sclerosing Cholangitis, Inborn Disorder of Bile Acid Synthesis, Tyrosinemia, Budd-Chiari Syndrome, Cholestasis, Glycogen Storage Disease, Neonatal Hemochromatosis, Urea Cycle Disorder, Hepatitis C Virus Infection, Hepatitis B Virus Infection, Bile Duct Disorder, Primary Hyperoxaluria, Autoimmune Hepatitis, Hepatitis A Virus Infection, Hepatocellular Carcinoma, Alpha 1-Antitrypsin Deficiency, Biliary Atresia, Isolated Congenital Hepatic Fibrosis, Hepatoblastoma, Acute Liver Failure
Lymphoproliferative Disease, Transplant Rejection Incidence, Liver Diseases, Epstein Barr Virus/Lymphoproliferative Disease (EBV/LPD), Immunosuppressive Therapy, Liver Translantation, Graft Survival
Division of Digestive Diseases and Nutrition
Document Name | Description | Document Type | File Format | Compliance | Download |
|---|---|---|---|---|---|
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
Family History of Heart Disease and Diabetes Dataset | Captures family history of heart disease and diabetes data (1st transplant sequence) | sas7bdat (209 KB) | ||
Status 1 Outcome Dataset | Captures labs and events at removal from status 1 listing pre-transplant | sas7bdat (49 KB) | ||
Pre-Transplant Follow-Up Dataset | Captures data every 6 months (up to 2 years) then annual until transplant, exit, lost to follow-up, or death pre-transplant | sas7bdat (4.86 MB) | ||
Transplant Surgical Dataset | Captures anastomosis and closure dates at time of transplant; completed by attending surgeon (1st transplant sequence) | sas7bdat (2.05 MB) | ||
Rejection Dataset | Captures rejection data (1st transplant sequence) | sas7bdat (1.59 MB) | ||
Ecsplita Dataset | Age at listing evaluation. This dataset is not associated with a study data collection form. | sas7bdat (81 KB) | ||
ADHD Rating Scale IV Dataset | Captures child behavior data pre-transplant | sas7bdat (49 KB) | ||
Symptomatic EBV/LPD Follow-Up Dataset | Captures symptomatic EBV/LPD follow-up data (3rd EBV/LPB sequence) | sas7bdat (481 KB) | ||
Long-Term Post-Transplant Follow-Up Dataset | Captures assessments and complications data since last visit (1st transplant sequence) | sas7bdat (26.61 MB) | ||
Transplant Medications Dataset | Captures therapies and medications received within the first 30 days of transplant (1st transplant sequence) | sas7bdat (3.59 MB) | ||
Symptomatic EBV/LPD Evaluation Dataset | Captures symptomatic EBV/LPD evaluation data (3rd EBV/LPB sequence) | sas7bdat (177 KB) | ||
Status 1 Listing Dataset | Captures labs and symptoms at status 1 pre-transplant | sas7bdat (177 KB) | ||
Death Dataset | Captures death data pre-transplant | sas7bdat (81 KB) | ||
Transplant Baseline Dataset | Captures demographic and clinical data within 48 hours of transplant (1st transplant sequence) | sas7bdat (1.99 MB) | ||
Re-Transplant Evaluation Dataset | Captures data at re-transplant listing (1st transplant sequence) | sas7bdat (225 KB) | ||
Long-Term Medications Dataset | Captures immunosuppressants, antivirals, and concomitant medications data (1st transplant sequence) | sas7bdat (15.86 MB) | ||
Transplant Early Follow-Up Dataset | Captures hospitalization, complications, and chemistries at 30 days post-transplant (1st transplant sequence) | sas7bdat (3.92 MB) | ||
Autoimmune Hepatitis Dataset | Captures autoimmune hepatitis type pre-transplant | sas7bdat (33 KB) | ||
Demographics Dataset | Captures demographics and primary liver disease diagnosis data pre-transplant | sas7bdat (704 KB) | ||
Primary Sclerosing Cholangitis Dataset | Captures primary sclerosing cholangitis data pre- and post-first transplant information | sas7bdat (49 KB) | ||
School Attendance and Performance Survey Dataset | Captures data from the School Attendance and Performance Survey (1st transplant sequence) | sas7bdat (6.16 MB) | ||
Pre-Transplant Evaluation Dataset | Captures data at transplant listing pre-transplant | sas7bdat (2.89 MB) | ||
Lost to Follow-Up/Exit Dataset | Captures lost to follow-up/early exit data pre-transplant | sas7bdat (225 KB) |