ADLDT: An Opportunity to Expand the National Donor Pool

ADLDT：扩大国家捐助库的机会

• 批准号: 7120588
• 负责人: Rafik MARK GHOBRIAL
• 金额: $ 28.09万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-17 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7120588
• 关键词: adult human (21+); clinical research; cooperative study; epidemiology; hepatitis C virus; human middle age (35-64); human subject; information systems; liver regeneration; liver transplantation; longitudinal human study; outcomes research; patient oriented research; postoperative complications; postoperative state; questionnaires; tissue donors

DESCRIPTION (provided by applicant):The overall objective of this proposal is to establish a Clinical Research Consortium to define the outcomes of ALDLT. We propose the following specific aims to fully evaluate the impact of ALDLT: 1. Core Study: Establish a Donor and Recipient Core Information Database for Adult LDLT and Non-ALDLT Patients Hypothesis: ALDLT short-term survival outcomes, but not complication rates, are equivalent to whole cadaveric and SLT transplantation. We and others, achieved excellent short-tem survival outcomes of ALDLT, despite a high rate of recipient complications, in non-urgent patients. To fully evaluate the benefits of ALDLT, the technique will be applied to both urgent and non-urgent recipients, and compare its outcomes to three sets of patient cohorts that include: a) whole organ recipients, b) cadaveric SLT recipients, and c) candidates who ultimately do not receive a transplant. The living donor section will compare living donors and potential donors who do not undergo donation. Primary endpoints define survival outcomes and complication rates in donors and recipients at 1, 2 and 3 years posttransplantation. This will elucidate the efficacy of ALDLT as compared to whole cadaveric, SLT, and control (untransplanted) patients in the entire spectrum of recipients' status, and determine if ALDLT is justified when compared to the natural history of non-transplanted non-urgent controls. Secondary endpoints assess the impact of technical variations on postoperative recovery, liver regeneration postdonation, impact of living donation on the cadaveric donor pool, and defines donor exclusion criteria.2. Clinical Research Protocol for Recipient Outcome: Determine the impact of ALDLT on Posttransplant HCV Recurrence in Transplant Recipients Hypothesis: ALDLT may be accompanied by accelerated recurrence of HCV versus whole cadaveric liver transplantation. Rapid and severe HCV recurrence observed, at our center, in ALDLT recipients compared to whole organ transplant patients, may offset the benefits of early transplantation with living donors. This protocol compares the time to histological recurrence of HCV in ALDLT and whole organ graft recipients at 6 months, 1, 2, and 3 years posttransplantation. The effects on patient and graft survival and the correlation between the degree of histological disease and HCV RNA levels are investigated by our secondary endpoints.3. Clinical Research Protocol for Donor Outcome: Determine Health-Related Quality of Life Outcomes and Resource Utilization of Adult Living Donation Hypothesis: HRQL of living donors is impacted in the short-, but not, the long-term and the HRQL of ALDLT recipients may be enhanced following ALDLT. HRQL in both donors and recipients will be compared before ALDLT and at 6 and 12 months posttransplantation through generic and disease-specific instruments. Additionally, health utility index assessments and evaluation of health care resource utilization will be conducted.

描述（由申请人提供）：该提案的总体目的是建立一个临床研究联盟来定义ALDLT的结果。我们提出了以下具体目的，旨在充分评估ALDLT的影响：1。核心研究：为成人LDLT和非ALDLT患者假设建立一个供体和受体核心信息数据库：ALDLT短期生存结果，但不是并发率，但并非并发率与整个尸体和SLT移植相同。我们和其他人在非紧迫性患者中，尽管受体并发症的率很高，但ALDLT的出色短TEM生存结果。为了充分评估ALDLT的好处，该技术将应用于紧急和非紧急接收者，并将其结果与三组患者同类群体进行比较，其中包括：a）a）整个器官受体，b）尸体SLT接收者以及C）最终未接受A胎的候选者。活着的捐助者部分将比较不接受捐款的活捐助者和潜在的捐助者。主要终点定义了移植后1、2和3年的供体和接受者的生存结果和并发症率。与整个受体状态相比，与整个尸体，SLT和对照（未转移）患者相比，ALDLT的疗效将阐明ALDLT的疗效，并确定与非转移非植入非育心对照的自然史相比，确定ALDLT是否合理。次要终点评估技术变化对术后恢复，肝脏再生后的影响，生活捐赠对尸体供体池的影响，并定义了供体排除标准。2。接受者结果的临床研究方案：确定ALDLT对移植受者移植后HCV复发的影响：ALDLT可能伴随HCV与整个尸体肝移植的加速复发。与整个器官移植患者相比，在我们的中心，在我们的中心，在我们的中心，快速和严重的HCV复发可能抵消了活着的捐助者早期移植的好处。该协议将6个月，1、2和3年后的ALDLT和整个器官移植受体中HCV的组织学复发进行比较。我们的次要终点研究了对患者和移植物生存的影响以及组织学疾病与HCV RNA水平之间的相关性。3。捐助者结果的临床研究方案：确定与健康相关的生活质量和成人生活捐赠假设的资源利用：在短期内，ALDLT接收者的长期和HRQL在ALDLT后可能会受到影响，但没有影响活跃捐助者的HRQL。捐助者和接受者的HRQL将在ALDLT之前通过通用和疾病特异性的仪器进行比较，并在移植后6和12个月进行比较。此外，还将进行健康公用事业指数评估和卫生保健资源利用率的评估。