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.
Liver Disease, Diabetes, Endocrine Diseases and Metabolic Diseases
Observational
3
End Stage Renal Failure
Hepatic Etiologies, Renal Insufficiency, Orthotopic Liver Transplantation (OLT), Postoperative, Cardiovascular Diseases, Post-Transplant Outcomes, Liver Diseases
Division of Digestive Diseases and Nutrition
Document Name | Description | Document Type | File Format | Compliance | Download |
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Document Name | Description | Document Type | File Format |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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LTD1 Form DF Dataset | Contains data obtained from Form DF - Donor Form | 983 | csv (745.89 KB); sas7bdat (2.79 MB) | |
LTD1 Form MF Dataset | Contains data obtained from Form MF - Complications | 5035 | csv (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 2002 | 1311 | csv (503.46 KB); sas7bdat (2.18 MB) | |
LTD2 Form LT - Hospitalizations Dataset | Dataset of all hospitalizations recorded on the LT form | 914 | csv (85.6 KB); sas7bdat (177 KB) | |
LTD1 Form IA Dataset | Contains data obtained from Form IA - Anesthesiology Study | 499 | csv (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 sample | 743 | csv (73.68 KB); sas7bdat (256 KB) | |
LTD1 Form LC Dataset | Contains data obtained from Form LC - Living Donor Follow-Up Complications | 9 | csv (10.29 KB); sas7bdat (80 KB) | |
LTD1 Form PB Dataset | Contains data obtained from Form PB - Back Table Day 0/1 Histology Findings | 498 | csv (154.54 KB); sas7bdat (208 KB) | |
LTD1 Form SL Dataset | Contains data obtained from Form SL - Screening Log | 1869 | csv (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 vial | 312 | csv (39.03 KB); sas7bdat (97 KB) | |
LTD1 Form CE Dataset | Contains data obtained from Form CE - Initial Evaluation | 1526 | csv (3.32 MB); sas7bdat (8.5 MB) | |
LTD1 Form CP Dataset | Contains data obtained from Form CP - Immediate Pre-Operative | 968 | csv (1.34 MB); sas7bdat (1.67 MB) | |
LTD1 Form DS Dataset | Contains data obtained from Form DS - Donor Liver Surgeon Assessment | 940 | csv (194.24 KB); sas7bdat (884 KB) | |
LTD1 Form YP Dataset | Contains data obtained from Form YP - Yearly Pre-Transplant Follow-Up | 965 | csv (91.15 KB); sas7bdat (144 KB) | |
LTD1 Form PP Dataset | Contains data obtained from Form PP - Post-Transplant Pathology: Histology Findings | 6750 | csv (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 Bank | 14139 | sas7bdat (3 MB); csv (1.23 MB) | |
LTD2 Form LT - Neoplasia Dataset | Dataset of all episodes of neoplasia recorded on the LT form | 324 | csv (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) | 430 | sas7bdat (56 KB); csv (27.12 KB) | |
LTD1 Form FI Dataset | Contains data obtained from Form FI - Post Transplant Follow-Up ICP Monitoring | 33 | csv (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 donors | 320 | sas7bdat (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-transplant | 91 | csv (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 disease | 771 | sas7bdat (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 contact | 916 | csv (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 donors | 374 | sas7bdat (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 units | 55 | csv (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 2002 | 113 | csv (48.57 KB); sas7bdat (384 KB) | |
LTD1 Form MD Dataset | Contains data obtained from Form MD - Death Report | 464 | csv (147.12 KB); sas7bdat (160 KB) | |
LTD2 Form LT - Graft Dysfunction Dataset | Dataset of all episodes of graft dysfunction recorded on the LT form | 475 | csv (43.38 KB); sas7bdat (113 KB) | |
LTD1 Form FK Dataset | Contains data obtained from Form FK - FK506 Study Dosage Change | 104 | csv (105.46 KB); sas7bdat (208 KB) | |
LTD2 HCV Genotype Dataset | Contains HCV genotype information for Dr. DiBisceglie analysis | 31 | csv (1.76 KB); sas7bdat (13 KB) | |
LTD1 Form CU Dataset | Contains data obtained from Form CU - CMV Status | 5 | csv (243 B); sas7bdat (24 KB) | |
LTD1 Form FS Dataset | Contains data obtained from Form FS - Fulminant Form | 90 | csv (279.65 KB); sas7bdat (1 MB) | |
LTD1 Form PG Dataset | Contains data obtained from Form PG - Post-Transplant Pathology: Failed Allografts and Autopsies | 170 | csv (85.87 KB); sas7bdat (320 KB) | |
LTD1 Form CS Dataset | Contains data obtained from Form CS - Change of Status | 605 | csv (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 forms | 1467 | sas7bdat (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 comments | 757 | csv (2.32 MB); sas7bdat (7.5 MB) | |
LTD1 Form IS Dataset | Contains data obtained from Form IS - Intra-Operative Surgeon Assessment | 1002 | csv (338.33 KB); sas7bdat (432 KB) | |
LTD2 Form LT - Biopsies Dataset | Dataset of all biopsies recorded on the LT form | 992 | csv (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 transplant | 359 | csv (125.61 KB); sas7bdat (672 KB) | |
LTD1 Form MC Dataset | Contains data obtained from Form MC - CMV Disease | 355 | csv (365.69 KB); sas7bdat (512 KB) | |
LTD1 Form IO Dataset | Contains data obtained from Form IO - Inter-Operative Procedure | 1002 | csv (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 transplantation | 566 | sas7bdat (56 KB); csv (29.28 KB) | |
LTD1 Form LD Dataset | Contains data obtained from Form LD - Living Donor | 19 | csv (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 transplantation | 669 | sas7bdat (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 Form | 827 | csv (191.89 KB); sas7bdat (1008 KB) | |
LTD2 Clinical Lab - LB Form/Hospital Databases Dataset | All clinical lab data obtained from hospital databases and LB forms | 137170 | csv (6.29 MB); sas7bdat (11.66 MB) | |
LTD1 Form NR Dataset | Contains data obtained from Form NR - No Rejection Clinically Diagnosed | 223 | csv (40.85 KB); sas7bdat (76.5 KB) | |
LTD1 Form CM Dataset | Contains data obtained from Form CM - CMV Study-Dosage Change Form | 609 | csv (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 dataset | 8018 | csv (2.81 MB); sas7bdat (12.23 MB) | |
LTD1 Form CD Dataset | Contains data obtained from Form CD - Change of Diagnosis for Native Liver | 29 | csv (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) | 263 | csv (269.74 KB); sas7bdat (561 KB) | |
LTD1 Form LF Dataset | Contains data obtained from Form LF - Liver Donor Follow-Up | 153 | csv (40.3 KB); sas7bdat (101.5 KB) | |
LTD1 Form DR Dataset | Contains data obtained from Form DR - Donor Liver Recovery | 983 | csv (404.32 KB); sas7bdat (464 KB) | |
LTD1 Form FF Dataset | Contains data obtained from Form FF - Final Follow-Up | 718 | csv (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) | 444 | csv (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-transplantation | 30 | csv (3.36 KB); sas7bdat (128 KB) | |
LTD1 Form QP Dataset | Contains data obtained from Form QP - Quality of Life: Children | 274 | csv (79.69 KB); sas7bdat (256 KB) | |
LTD2 Form LX - Complications Dataset | Dataset of all complications recorded on the LX form | 2278 | csv (181.04 KB); sas7bdat (369 KB) | |
LTD1 Form CO Dataset | Contains data obtained from Form CO - Post-Transplant Long-Term Follow-Up | 2930 | csv (2.7 MB); sas7bdat (7.27 MB) | |
LTD1 Form RU Dataset | Contains data obtained from Form RU - Rejection Update | 337 | csv (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 conditions | 165 | csv (54.02 KB); sas7bdat (448 KB) | |
LTD2 Form LT - Medications Dataset | Dataset of all medications recorded on the LT form | 2115 | csv (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 Medications | 5658 | csv (8.76 MB); sas7bdat (12.02 MB) | |
LTD1 Form CI Dataset | Contains data obtained from Form CI - Post-Transplant Short-Term Follow-Up | 7582 | csv (2.46 MB); sas7bdat (3.06 MB) | |
LTD1 Form QA Dataset | Contains data obtained from Form QA - Quality of Life: Adults | 2805 | csv (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) | 8 | csv (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, CRP | 145 | csv (9.74 KB); sas7bdat (33 KB) | |
LTD1 Form PO Dataset | Contains data obtained from Form PO - Pathology for Native Liver | 916 | csv (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 forms | 920 | sas7bdat (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) | 753 | csv (308.1 KB); sas7bdat (387.5 KB) | |
LTD1 Form PS Dataset | Contains data obtained from Form PS - Post-Transplant Status | 131 | csv (7.8 KB); sas7bdat (32 KB) | |
LTD2 Form LX - Treated Infections Dataset | Dataset of all treated infections recorded on the LX form | 571 | csv (42.85 KB); sas7bdat (85 KB) | |
LTD1 Form MR Dataset | Contains data obtained from Form MR - Complications - Rejection | 1029 | csv (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 collection | 30 | csv (2.07 KB); sas7bdat (9 KB) | |
LTD1 Form ST Dataset | Contains data obtained from Form ST - Study Log | 1828 | csv (107.87 KB); sas7bdat (160 KB) |