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Citation
Belle, Steven (2024). Liver Transplantation Database (LTD/LTD2) (Version 3) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/cdrd-9105
Data Availability Statement
Data from Liver Transplantation Database (LTD/LTD2) [(Version 3) https://doi.org/10.58020/cdrd-9105] 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 LTD/LTD2 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 LTD/LTD2 (https://doi.org/10.58020/cdrd-9105) 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 LTD/LTD2 study and does not necessarily reflect the opinions or views of the LTD/LTD2 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 3 (Updated on: Oct 29, 2024)
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  • Data Available for Request
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General Description

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.

Objectives

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.

Outcome Measure

Mortality rates, cause of death, and risk factors were evaluated for all patients in the follow-up cohort.

Eligibility Criteria

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.

Outcome

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.

Research Area

Liver Disease, Diabetes, Endocrine Diseases and Metabolic Diseases

Study Type

Observational

Study Sites

3

Condition

End Stage Renal Failure

Keywords

Hepatic Etiologies, Renal Insufficiency, Orthotopic Liver Transplantation (OLT), Postoperative, Cardiovascular Diseases, Post-Transplant Outcomes, Liver Diseases

NIDDK Division

Division of Digestive Diseases and Nutrition

1,869
Participants

Target Population
Children, Adults, Transplant Patients

Public Documents Table
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Non-Public Documents (3)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
Datasets (123)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
LTD1 Form DF Dataset
Contains data obtained from Form DF - Donor Form983csv (745.89 KB); sas7bdat (2.79 MB)
LTD1 Form MF Dataset
Contains data obtained from Form MF - Complications5035csv (11.76 MB); sas7bdat (21.5 MB)
LTD2 Form QA Dataset
Contains all data recorded on the Quality of Life Adult Form (QA). Questionnaires were mailed annually to participants age 16 and older from 1999 to 20021311csv (503.46 KB); sas7bdat (2.18 MB)
LTD2 Form LT - Hospitalizations Dataset
Dataset of all hospitalizations recorded on the LT form914csv (85.6 KB); sas7bdat (177 KB)
LTD1 Form IA Dataset
Contains data obtained from Form IA - Anesthesiology Study499csv (74.06 KB); sas7bdat (112 KB)
LTD2 Form TR Dataset
Contains information about patient consent status including serum storage consent concerning the year 8 blood sample including post-death consent (or non-consent) to use serum and the wishes of the patient regarding outside research and the use of their serum sample743csv (73.68 KB); sas7bdat (256 KB)
LTD1 Form LC Dataset
Contains data obtained from Form LC - Living Donor Follow-Up Complications9csv (10.29 KB); sas7bdat (80 KB)
LTD1 Form PB Dataset
Contains data obtained from Form PB - Back Table Day 0/1 Histology Findings498csv (154.54 KB); sas7bdat (208 KB)
LTD1 Form SL Dataset
Contains data obtained from Form SL - Screening Log1869csv (93.99 KB); sas7bdat (256 KB)
LTD2 Form SS Dataset
Contains all data recorded on the Serum Storage Form (SS). Catalog information on the year-8 blood sample stored with the MAYO serum bank. Variables include date of blood draw, quality of the blood sample, the number of vials stored and the storage vial Identification number for each vial312csv (39.03 KB); sas7bdat (97 KB)
LTD1 Form CE Dataset
Contains data obtained from Form CE - Initial Evaluation1526csv (3.32 MB); sas7bdat (8.5 MB)
LTD1 Form CP Dataset
Contains data obtained from Form CP - Immediate Pre-Operative968csv (1.34 MB); sas7bdat (1.67 MB)
LTD1 Form DS Dataset
Contains data obtained from Form DS - Donor Liver Surgeon Assessment940csv (194.24 KB); sas7bdat (884 KB)
LTD1 Form YP Dataset
Contains data obtained from Form YP - Yearly Pre-Transplant Follow-Up965csv (91.15 KB); sas7bdat (144 KB)
LTD1 Form PP Dataset
Contains data obtained from Form PP - Post-Transplant Pathology: Histology Findings6750csv (2.05 MB); sas7bdat (7.22 MB)
LTD1 Serum Bank Form SS - Serum Storage Dataset
A vial-specific inventory of all 14,139 vials stored in the Serum Bank14139sas7bdat (3 MB); csv (1.23 MB)
LTD2 Form LT - Neoplasia Dataset
Dataset of all episodes of neoplasia recorded on the LT form324csv (26.53 KB); sas7bdat (65 KB)
LTD1 Serum Bank Positive EIA-2 Results Retest Dataset
Provides confirmation of 430 positive EIA-2 test results for 245 patients and donors, utilizing a commercially bought second generation 4-antigen recombinant immunoblot assay (RIBA-2, Chiron, Emeryville, CA)430sas7bdat (56 KB); csv (27.12 KB)
LTD1 Form FI Dataset
Contains data obtained from Form FI - Post Transplant Follow-Up ICP Monitoring33csv (18.11 KB); sas7bdat (80 KB)
LTD1 Serum Bank HGV RNA Using RT-PCR Test Dataset
Contains 320 tests for hepatitis G virus (HGV) RNA by reverse -transcription-polymerase chain reaction (RT-PCR) on 188 patients and donors320sas7bdat (40 KB); csv (11.38 KB)
LTD2 Form PA Dataset
Contains all data recorded on the Physical Activity Assessment Form (PA). Includes results of telephone interviews conducted by Shannon FitzGerald on adult patients who were >=7 years post-transplant91csv (82.08 KB); sas7bdat (708 KB)
LTD2 Form LT Dataset
Contains all data recorded on the LT portion of the Long Term Follow-Up Form of Clinical and Laboratory Data. Includes hospitalizations, graft dysfunctions, neoplasia and recurrence of disease771sas7bdat (8 MB); csv (2.56 MB)
LTD2 Demographics Dataset
Contains basic demographic information for all 916 transplanted patients who participated in LTD1. The variable N728 indicates the patient is among the 728 patients who were alive at the beginning of the LTD2 study. Other data contained in clip includes transplant dates, diagnoses, mortality status and date of last LTD contact916csv (154.92 KB); sas7bdat (488 KB)
LTD1 Serum Bank PCR Test for HCV RNA Dataset
Contains 374 tests for HCV RNA by a non-commercial, double nested polymerase chain reaction (PCR) method (note 4, below) on 105 patients and donors374sas7bdat (40 KB); csv (15.69 KB)
LTD2 HCV Viral Load Dataset
Contains results of viral load testing on the long term (year 8) serum of HCV positive patients who submitted a blood sample. Viral levels recorded in copies and internation units55csv (5.71 KB); sas7bdat (17 KB)
LTD2 Form QP Dataset
Contains all data recorded on the Quality of Life Pediatric Form (QP). Questionnaires were mailed annually to transplant recipients age 16 and under from 1999 to 2002113csv (48.57 KB); sas7bdat (384 KB)
LTD1 Form MD Dataset
Contains data obtained from Form MD - Death Report464csv (147.12 KB); sas7bdat (160 KB)
LTD2 Form LT - Graft Dysfunction Dataset
Dataset of all episodes of graft dysfunction recorded on the LT form475csv (43.38 KB); sas7bdat (113 KB)
LTD1 Form FK Dataset
Contains data obtained from Form FK - FK506 Study Dosage Change104csv (105.46 KB); sas7bdat (208 KB)
LTD2 HCV Genotype Dataset
Contains HCV genotype information for Dr. DiBisceglie analysis31csv (1.76 KB); sas7bdat (13 KB)
LTD1 Form CU Dataset
Contains data obtained from Form CU - CMV Status5csv (243 B); sas7bdat (24 KB)
LTD1 Form FS Dataset
Contains data obtained from Form FS - Fulminant Form90csv (279.65 KB); sas7bdat (1 MB)
LTD1 Form PG Dataset
Contains data obtained from Form PG - Post-Transplant Pathology: Failed Allografts and Autopsies170csv (85.87 KB); sas7bdat (320 KB)
LTD1 Form CS Dataset
Contains data obtained from Form CS - Change of Status605csv (68.52 KB); sas7bdat (96 KB)
LTD1 Serum Bank Anti-HCV Test Dataset
Contains 1,467 tests for anti-HCV on 768 patients and donors who did not have second generation test results recorded on the LTD forms1467sas7bdat (88 KB); csv (48.85 KB)
LTD2 Form LX Dataset
Contains all data recorded on the LX portion of the Long Term Follow-Up Form of Clinical and Laboratory Data. Includes major events/conditions, treated infections and comments757csv (2.32 MB); sas7bdat (7.5 MB)
LTD1 Form IS Dataset
Contains data obtained from Form IS - Intra-Operative Surgeon Assessment1002csv (338.33 KB); sas7bdat (432 KB)
LTD2 Form LT - Biopsies Dataset
Dataset of all biopsies recorded on the LT form992csv (43.74 KB); sas7bdat (81 KB)
LTD2 Form QW Dataset
Contains all data recorded on the Quality of Life Adult Return to Work Form (QW). Includes employment status data collected on a once per-study questionnaire completed by adult patients (age >16 and not <16 at the time of first transplantation) near the 7th anniversary of the patient's first transplant359csv (125.61 KB); sas7bdat (672 KB)
LTD1 Form MC Dataset
Contains data obtained from Form MC - CMV Disease355csv (365.69 KB); sas7bdat (512 KB)
LTD1 Form IO Dataset
Contains data obtained from Form IO - Inter-Operative Procedure1002csv (699.5 KB); sas7bdat (832 KB)
LTD1 Serum Bank PCR Test for HBV DNA Dataset
Contains 566 tests for HBV DNA by PCR on 158 patients and donors who were the first 158 LTD patients to survive at least one year after liver transplantation566sas7bdat (56 KB); csv (29.28 KB)
LTD1 Form LD Dataset
Contains data obtained from Form LD - Living Donor19csv (20.49 KB); sas7bdat (456 KB)
LTD1 Serum Bank Form MT - Molecular Testing for HCV Dataset
Contains 669 results of HCV molecular testing on 325 patients and donors who were EIA-2 positive, or had a diagnosis of hepatitis C before or after transplantation669sas7bdat (120 KB); csv (107.16 KB)
LTD2 Pathology Findings Dataset
Pathology findings from LTD2's central pathologist A.J. Demetris MD recorded on a MS Access version of the PP Form827csv (191.89 KB); sas7bdat (1008 KB)
LTD2 Clinical Lab - LB Form/Hospital Databases Dataset
All clinical lab data obtained from hospital databases and LB forms137170csv (6.29 MB); sas7bdat (11.66 MB)
LTD1 Form NR Dataset
Contains data obtained from Form NR - No Rejection Clinically Diagnosed223csv (40.85 KB); sas7bdat (76.5 KB)
LTD1 Form CM Dataset
Contains data obtained from Form CM - CMV Study-Dosage Change Form609csv (224.48 KB); sas7bdat (336 KB)
LTD2 All Pathology Dataset
All pathology data from LTD1 and LTD2. This data is compiled from the PP and PG forms and the LTD2 Pathology Findings dataset8018csv (2.81 MB); sas7bdat (12.23 MB)
LTD1 Form CD Dataset
Contains data obtained from Form CD - Change of Diagnosis for Native Liver29csv (9.58 KB); sas7bdat (64 KB)
LTD2 Clinical Lab - Patient Chart Dataset
Clinical lab data as recorded from the patient chart; this form was completed by MAYO only (the information is duplicated in LTD2 Clinical Lab - LB Form/Hospital Databases Dataset)263csv (269.74 KB); sas7bdat (561 KB)
LTD1 Form LF Dataset
Contains data obtained from Form LF - Liver Donor Follow-Up153csv (40.3 KB); sas7bdat (101.5 KB)
LTD1 Form DR Dataset
Contains data obtained from Form DR - Donor Liver Recovery983csv (404.32 KB); sas7bdat (464 KB)
LTD1 Form FF Dataset
Contains data obtained from Form FF - Final Follow-Up718csv (84.03 KB); sas7bdat (136 KB)
LTD2 Form PP Dataset
Contains all data recorded on the Post-Transplant Pathology Histology Findings Form (PP) (form was completed by MAYO pathologist only)444csv (160.74 KB); sas7bdat (812 KB)
LTD2 Form RX Dataset
Contains all data recorded on the Re-transplantation Form (RX). Data includes date of re-transplant if it occurred during LTD2 as well as reasons for re-transplantation30csv (3.36 KB); sas7bdat (128 KB)
LTD1 Form QP Dataset
Contains data obtained from Form QP - Quality of Life: Children274csv (79.69 KB); sas7bdat (256 KB)
LTD2 Form LX - Complications Dataset
Dataset of all complications recorded on the LX form2278csv (181.04 KB); sas7bdat (369 KB)
LTD1 Form CO Dataset
Contains data obtained from Form CO - Post-Transplant Long-Term Follow-Up2930csv (2.7 MB); sas7bdat (7.27 MB)
LTD1 Form RU Dataset
Contains data obtained from Form RU - Rejection Update337csv (268.31 KB); sas7bdat (888 KB)
LTD2 Form MD Dataset
Contains all data recorded on the Mortality Determination Form (MD). Data includes major cause of death and associated conditions165csv (54.02 KB); sas7bdat (448 KB)
LTD2 Form LT - Medications Dataset
Dataset of all medications recorded on the LT form2115csv (188.46 KB); sas7bdat (449 KB)
LTD1 Form MP Dataset
Contains data obtained from Form MP - Post Transplant Follow-Up Short-Term Immunosuppressive Medications and Other Medications5658csv (8.76 MB); sas7bdat (12.02 MB)
LTD1 Form CI Dataset
Contains data obtained from Form CI - Post-Transplant Short-Term Follow-Up7582csv (2.46 MB); sas7bdat (3.06 MB)
LTD1 Form QA Dataset
Contains data obtained from Form QA - Quality of Life: Adults2805csv (720.36 KB); sas7bdat (1.44 MB)
LTD2 Form PG Dataset
Contains all data recorded on the Gross Pathology of Excised Graft Form (PG). Data includes biopsy data from the excised liver for patients who were re-transplanted during LTD2 (form was completed by the MAYO pathologist only)8csv (5.62 KB); sas7bdat (344 KB)
LTD2 Pre-Op Blood Lab Dataset
Contains lab results on pre-op blood samples for Dr. S. Weston analysis. Labs include HDL, LDL, triglycerides, CRP145csv (9.74 KB); sas7bdat (33 KB)
LTD1 Form PO Dataset
Contains data obtained from Form PO - Pathology for Native Liver916csv (410.85 KB); sas7bdat (384 KB)
LTD1 Serum Bank Form VB - Hepatitis B Testing Dataset
Contains 920 hepatitis B tests on 580 patients and donors who did not have test results recorded on the LTD forms920sas7bdat (512 KB); csv (144.85 KB)
LTD1 Form ES Dataset
Contains data obtained from Form ES - End of Study Assessments Pediatric (full follow-up required)753csv (308.1 KB); sas7bdat (387.5 KB)
LTD1 Form PS Dataset
Contains data obtained from Form PS - Post-Transplant Status131csv (7.8 KB); sas7bdat (32 KB)
LTD2 Form LX - Treated Infections Dataset
Dataset of all treated infections recorded on the LX form571csv (42.85 KB); sas7bdat (85 KB)
LTD1 Form MR Dataset
Contains data obtained from Form MR - Complications - Rejection1029csv (1.34 MB); sas7bdat (3.06 MB)
LTD2 Corrections of LTD1 Data Dataset
Contains corrections to LTD1 data that were submitted by the nurse coordinators during LTD2 data collection30csv (2.07 KB); sas7bdat (9 KB)
LTD1 Form ST Dataset
Contains data obtained from Form ST - Study Log1828csv (107.87 KB); sas7bdat (160 KB)