跳至主要内容
临床试验/NCT00096733
NCT00096733已完成不适用

Adult-to-Adult Living Donor Liver Transplantation Cohort Study

Arbor Research Collaborative for Health9 个研究点 分布在 1 个国家目标入组 2,470 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,470
试验地点
9
主要终点
Survival of the potential liver transplant recipient

研究概览

简要总结

There are two principal purposes of this study: 1) to determine whether it is more beneficial for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT) or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver donation on the donor's health and quality of life.

详细描述

Adult to adult living donor liver transplantation (LDLT) is a relatively new procedure increasingly used at major transplantation centers. Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers. Therefore, a network of nine leading liver transplantation centers and a data coordination center (DCC) has been organized to accrue and follow sufficient numbers of patients being considered for and undergoing LDLT to provide generalizable results from adequately powered studies. This network has established the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) that will conduct both retrospective and prospective studies of LDLT.

The primary study objective is to analyze the effect of choosing to pursue living liver donation. The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated (at least a history and physical examination). Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT. The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant. Finally, a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure.

Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Survival of the potential liver transplant recipient

时间窗: Time from living donor evaluation to death

Time from evaluation of a living liver donor until death of the potential recipient, to test the benefit of living liver donation.

次要结局

  • Recipient survival from time of transplant (either living or deceased donor)(From transplant until death or last follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

Loading locations...

相似试验