Liver Transplantation Database (LTD/LTD2)
Number of Subjects in Study Archive: 916 for LTD; 798 for Follow-Up Study
Study Design: Cohort
Conditions: Liver Diseases
Duration: 1990 – 2003
# Recruitment Centers: 3
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: Liver Transplant
Does it have dialysis patients: No
The NIDDK Liver Transplantation Database was established to prospectively investigate questions related to the experience of patients evaluated for and undergoing liver transplantation. The LTD contains data for 1563 patients referred and evaluated for orthotopic liver transplantation (OLT) at three large liver transplant centers in the United States; of these patients, 916 underwent transplantation and were followed for 1 to 5 years.
All patients referred for OLT were screened for eligibility to be entered in the database, which required informed consent, no prior liver transplant, and availability to be followed. For each participant, standardized data was collected on demographics, medical history, preoperative and post-transplant symptoms and quality of life, post-transplant complications, and mortality. Liver biopsies and serum samples were also obtained pre- and post-transplantation at intervals specified in the study protocol.
Following primary data collection, which occurred from April 1990 to June 1994, the Liver Transplantation Database Follow Up (LTD2) study was conducted to prospectively generate detailed survival data from a large multicenter cohort of liver transplant recipients. This study observed the long-term outcomes of transplantation to examine adverse effects, assess risk factors, and determine long-term mortality rates and causes of death post-transplant.
Follow-up data was obtained for 798 transplant patients from 1998 to 2003 at 3 clinical centers. Cause of death was captured in the early (≤ 1 year) and late (> 1 year and > 5 years) post-transplant periods. Patient-related risk factors were analyzed for overall deaths as well as for each major cause of death in the late post-transplant period. Adverse events, including complications of transplantation and recurrence or development of disease, were monitored.
The follow-up study identified common etiologies and risk factors that contributed to the morality of liver transplant patients at various stages post-transplantation. Results showed that hepatic etiologies were the most frequent cause of death in the late post-transplant setting. In addition to malignancy and cardiovascular disease, renal failure was found to be an important and escalating cause of death in the late post-transplant setting. Ancillary studies have also been performed on LTD data to evaluate pathology reliability and cost of liver transplantation, as well as examine various characteristics or biomarkers of collected serum.
The LTD was established to develop unified criteria for selection of patients for transplantation and for reporting and evaluating all data related to the outcome of the operation and the patients’ postoperative and long-term condition. The data was collected with the aim of better understanding the clinical aspects of liver transplantation.
The primary aim of the LTD Follow Up study was to determine patterns of and risk factors for long-term mortality using detailed survival from a large cohort of liver transplant recipients.
Mortality rates, cause of death, and risk factors were evaluated for all patients in the follow-up cohort.
Patients who were referred for liver transplantation at each recruitment center were eligible for the study if they were referred for liver transplantation, had no prior liver transplant, were available for follow-up, and provided informed consent.
The NIDDK Liver Transplantation Database has yielded comprehensive and high quality data and is a rich resource for extensive analysis about many important clinical aspects of liver transplantation. This data has been used to assess patient outcomes following OLT, to evaluate pathology reliability and cost of liver transplantation, and to examine various characteristics or biomarkers of collected serum. Specifically, the LTD Follow Up study identified common etiologies and risk factors that contributed to the morality of liver transplant patients at various stages post-transplantation. Results showed that hepatic etiologies were the most frequent cause of death in the late post-transplant setting. In addition to malignancy and cardiovascular disease, renal failure was found to be an important and escalating cause of death in the late post-transplant setting. Diabetes and renal insufficiency both pre- and post-transplant were identified as key factors in long-term survival after liver transplantation. Investigations into the effects of diligent medical management of diabetes, hypertension, and renal insufficiency in liver transplant patients are needed to assess the suitability of specific therapeutic interventions that may impact long-term morbidity and mortality.