Living Donor Liver Transplantation Cohort Study

活体肝移植队列研究

基本信息

批准号：
8015081
负责人：
CARL L. BERG
金额：
$ 6.16万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-02-15 至 2011-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8015081
关键词：
Acute Liver Failure Adult Allografting Cessation of life Child Chronic Chronic Hepatitis C Clinical Clinical Research Clinical Research Protocols Cohort Studies Counseling Data Data Collection Databases Decision Analysis Decision Making Development Dissection Drug Formulations Evaluation Factor Analysis Future Healthcare Systems Hepatitis C Hepatitis C virus Hepatocyte Heterogeneity Histologic Human Resources Infection Injury Institution Kinetics Lead Liver Liver diseases Living Donor Liver Transplantation Living Donors Medical Methods Modeling Molecular Virology Natural regeneration Operative Surgical Procedures Organ Outcome Pathway interactions Patients Policies Procedures Protocols documentation Reporting Research Research Personnel Research Proposals Role Serum Societies Staging Techniques Time Transplant Recipients Transplantation United Network for Organ Sharing United States Universities Viral Virginia cohort cost cost effectiveness data modeling liver transplantation multidisciplinary novel strategies patient population programs prospective receptor transplant database

项目摘要

DESCRIPTION (provided by applicant):As the disparity between number of potential liver transplant recipients and available cadaveric organs has widened, novel approaches have been developed to permit the successful transplantation of the largest possible number of patients with end-stage liver disease. The most promising of these strategies has involved the application of adult to adult living donor liver transplantation (LDLT). More than fifteen U.S. transplant centers have now utilized LDLT as a standard method for liver replacement. Despite the increasingly widespread application of this approach, considerable heterogeneity exists between centers regarding donor and recipient evaluation as well as the surgical techniques employed. Moreover, information is lacking regarding outcomes of this procedure for both donor and recipient, no data available to identify donors or recipients who may benefit most (or least) from this procedure, and no data to determine whether using LDLT is a cost-effective strategy. In this setting, we propose to participate as a transplant center (TC) in the LDLT Clinical Research Consortium. In this role, we propose to participate in the development of a prospective comprehensive data base and information core that will permit the dissection of the factors which lead to favorable, or unfavorable, outcomes in LDLT as compared to standard cadaveric transplantation. The existing UVA STRANDS database will permit retrospective collection of data from LDLT and cadaveric transplants performed over the last 5 years. In addition, the TC proposes to build on its institutional strengths to lead two clinical research protocols. The first protocol will develop a Cost Utility Decision Analysis using the Adult to Adult Living Donor Liver Transplantation Cohort. This research will yield a valid decision analysis model that can be used in a general patient population to better define subpopulations that would benefit from LDLT as opposed to cadaveric liver transplant. Costs and utilities to the health care system and the patients involved will be clarified for use in patient counseling, medical decision-making, and policy formulation. The second clinical research proposal will examine the outcomes of LDLT in patients infected with hepatitis C and compare these outcomes to cadaveric controls. Mechanisms that contribute to rapid allograft infection and injury will be examined including hepatocyte infection, rates of viral replication and kinetics of serum viral clearance.

描述（由申请人提供）：随着潜在肝移植受者数量与可用尸体器官之间的差距扩大，已经开发出新方法来允许最大可能数量的终末期肝病患者成功移植。这些策略中最有前途的是成人对成人活体肝移植（LDLT）的应用。超过 15 个美国移植中心现已采用 LDLT 作为肝脏替代的标准方法。尽管这种方法的应用日益广泛，但各中心之间在供体和受体评估以及所采用的手术技术方面存在相当大的异质性。此外，缺乏有关该程序对捐赠者和接受者的结果的信息，没有数据可用于确定可能从该程序中受益最多（或最少）的捐赠者或接受者，也没有数据可以确定使用 LDLT 是否是一种具有成本效益的策略。在这种情况下，我们建议作为移植中心 (TC) 参与 LDLT 临床研究联盟。在此角色中，我们建议参与开发一个前瞻性的综合数据库和信息核心，以便剖析与标准尸体移植相比导致 LDLT 有利或不利结果的因素。现有的 UVA STRANDS 数据库将允许回顾性收集过去 5 年进行的 LDLT 和尸体移植的数据。此外，TC 提议利用其机构优势来领导两项临床研究方案。第一个协议将使用成人至成人活体供肝移植队列开发成本效用决策分析。这项研究将产生一个有效的决策分析模型，可用于一般患者群体，以更好地定义受益于 LDLT 而非尸体肝移植的亚群。医疗保健系统和相关患者的成本和公用事业将得到澄清，用于患者咨询、医疗决策和政策制定。第二项临床研究计划将检查感染丙型肝炎患者的 LDLT 结果，并将这些结果与尸体对照进行比较。将检查导致快速同种异体移植物感染和损伤的机制，包括肝细胞感染、病毒复制速率和血清病毒清除动力学。