Adult-to-Adult Living Donor Liver Transplantation Study Data Coordinating Center

成人对成人活体肝移植研究数据协调中心

• 批准号: 8015789
• 负责人: Robert M Merion
• 金额: $ 41.92万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-15 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8015789
• 关键词: Address; Adherence; Adult; Adverse event; Ancillary Study; Annual Reports; Antiviral Therapy; Area; Biological Process; Biometry; Characteristics; Charge; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Cohort Studies; Collaborations; Collection; Committee Members; Communication; Communities; Data; Data Analyses; Data Base Management; Data Collection; Data Coordinating Center; Data Element; Data Quality; Databases; Development; Electronics; Enrollment; Ensure; Evaluation; Event; Future; Genes; Genomics; Goals; Grant; Health; Healthcare; Hepatitis C; Hepatitis C virus; Hepatology; Human Resources; Immunosuppression; Individual; Laboratories; Learning; Life; Liver; Liver Function Tests; Liver Regeneration; Living Donor Liver Transplantation; Living Donors; Lobe; Logistics; Longitudinal Studies; Manuals; Medical; Medical Economics; Monitor; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Natural regeneration; Organ Donor; Outcome; Personal Satisfaction; Persons; Pharmaceutical Preparations; Postoperative Period; Primary carcinoma of the liver cells; Principal Investigator; Privacy; Procedures; Process; Protocols documentation; Publications; Quality of life; Questionnaires; Records; Recovery; Recurrence; Reporting; Research; Research Design; Research Personnel; Resources; Safety; Scientist; Site; Societies; Structure; System; Testing; Time; Tissue Banks; Training and Education; Transplantation; United States Food and Drug Administration; Update; Work; data management; design; experience; follow-up; health related quality of life; improved; insight; interest; liver biopsy; liver function; named group; novel strategies; operation; preclinical study; prevent; prospective; public health relevance; repository; research study; response; restoration; sample collection; social; study characteristics; success

DESCRIPTION (provided by applicant): We propose to expand and maintain the Adult to Adult Living Donor Liver Transplantation Cohort Study Data Coordinating Center (A2ALL DCC) that will support a consortium of transplant centers in conducting continued observational and interventional research in living donor liver transplantation (LDLT) so as to facilitate understanding of the short and long-term medical and health-related quality of life outcomes of transplantation on living individuals who have donated a liver lobe as well as those who are candidates for and/or recipients of LDLT procedures. In addition, we will gain insight into liver regeneration and other biological processes through study of this unique procedure. The proposed DCC consists of the original A2ALL DCC team of collaborating experts in the fields of live organ donor transplantation, hepatology, clinical research design, database management, and research involving linkages of large public and private electronic health care databases. The DCC will continue to support the project, including research coordination, communications and logistics, study design, centralized data management, and analytical expertise. The specific scientific aims of the DCC will be developed in collaboration with the A2ALL Steering Committee. Proposed scientific activities include: 1) determination of long-term LDLT donor outcomes, including health-related quality of life, 2) protocols for immunosuppression minimization in the LDLT setting, 3) continued focus on hepatitis C and hepatocellular carcinoma, 4) identification of recipient and donor characteristics that are most favorable for LDLT, and 5) evaluation of newer approaches to LDLT to improve donor and recipient outcomes. PUBLIC HEALTH RELEVANCE: Society and the professional transplant community are obligated to past and future live organ donors and their recipients to learn from their experiences. Building on the success of the A2ALL consortium in achieving many of its original goals, several important research issues and clinical questions regarding LDLT still need to be addressed. Foremost among these issues is determining the long-term health and well-being of living liver donors. Understanding of the safety of LDLT must extend beyond short-term issues of post-operative complications of donors and recipients, resource utilization, recovery time, and restoration of adequate liver function. Critical to assessment of the long-term health of donors is comparison to persons with similar characteristics who did not donate. Important questions also remain regarding the use of LDLT in potential recipients: the possibility of immunosuppression minimization, use of LDLT grafts in special populations (e.g. persons with hepatocellular carcinoma and/or hepatitis C virus infection), and studying characteristics to identify those recipients who might do better with an LDLT graft than a DDLT graft. This study proposes to continue to use the structure built in the original project to answer these, key research questions.

描述（由申请人提供）：我们建议扩大和维持成人至成人活体供肝移植队列研究数据协调中心（A2ALL DCC），该中心将支持移植中心联盟开展活体供肝移植的持续观察和介入研究（LDLT），以促进了解捐献肝叶的活体个体以及候选者和/或肝叶移植者的短期和长期医疗和健康相关生活质量结果LDLT 手术的接受者。此外，我们将通过研究这一独特的过程来深入了解肝脏再生和其他生物过程。拟议的 DCC 由最初的 A2ALL DCC 团队组成，该团队由活体器官捐献者移植、肝病学、临床研究设计、数据库管理以及涉及大型公共和私人电子医疗保健数据库链接的研究领域的合作专家组成。 DCC 将继续支持该项目，包括研究协调、通信和后勤、研究设计、集中数据管理和分析专业知识。 DCC 的具体科学目标将与 A2ALL 指导委员会合作制定。拟议的科学活动包括：1) 确定长期 LDLT 捐献者的结局，包括与健康相关的生活质量，2) 在 LDLT 环境中最小化免疫抑制的方案，3) 继续关注丙型肝炎和肝细胞癌，4) 识别最有利于 LDLT 的接受者和捐赠者特征，以及 5) 评估新的 LDLT 方法以改善捐赠者和接受者的结果。 公共卫生相关性：社会和专业移植界有义务向过去和未来的活体器官捐献者及其接受者学习他们的经验。在 A2ALL 联盟成功实现其许多最初目标的基础上，有关 LDLT 的几个重要研究问题和临床问题仍然需要解决。这些问题中最重要的是确定活体肝脏捐赠者的长期健康和福祉。对 LDLT 安全性的理解必须超越供体和受体术后并发症、资源利用、恢复时间和恢复足够肝功能等短期问题。评估捐赠者长期健康状况的关键是与具有相似特征但未捐赠的人进行比较。关于在潜在接受者中使用 LDLT 的重要问题仍然存在：免疫抑制最小化的可能性、在特殊人群（例如患有肝细胞癌和/或丙型肝炎病毒感染的人）中使用 LDLT 移植物，以及研究特征以识别那些可能会出现以下情况的接受者： LDLT 移植物比 DDLT 移植物效果更好。本研究建议继续使用原始项目中构建的结构来回答这些关键研究问题。