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PLANNING A CLINICAL TRIAL TO PREVENT POSTTRANSPLANT ALD

规划预防移植后酒精性肝病 (ALD) 的临床试验

基本信息

批准号：
2894273
负责人：
THOMAS P BERESFORD
金额：
$ 6.3万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-09-30 至 2002-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2894273
关键词：
alcoholic hepatitis alcoholic liver cirrhosis alcoholism /alcohol abuse alcoholism /alcohol abuse therapy behavioral /social science research tag clinical research clinical trials ethanol health care service planning health services research tag homologous transplantation human subject liver transplantation longitudinal human study mental health services psychopharmacology

项目摘要

Hepatic transplant for persons suffering from alcohol dependence (AD) remains controversial medical issue. Despite three year data collected by the present PI and associates showing uniquely high abstinent rates in this highly selected population, any alcohol use post-transplant reaches as high as 35-40 percent. While rates of alcohol related mortality post-transplant, such as that from Alcoholic Liver Disease (ALD), remain low at about 1-5 percent, any mortality due to a preventable return to ethanol ingestion in an AD group is medically unacceptable and a threat to providing liver transplant for ALD. The outcome figures cited above suggest two phenomena: 1) the limit of AD patient selection in assuring long term abstinence, and 2) the need for specific treatment of this unique population whose natural abstinence rate far exceeds those found in non-transplant AD cases. Further, longitudinal data suggest 3) that alcohol related mortality occurs after the first year post-transplant, so called late deaths. A clear need exists to design and implement effective treatment for this unique clinical population that takes into account their already high abstinent rate and their course of increasing risk for alcoholic relapse and late death due to recurrent ALD or other AD related injury. The consortium of liver transplant centers proposes to design and propose a randomized clinical trial of focused, active, long-term follow-up care in a test group of 205 AD liver transplant recipients versus standard care given to a control group of 205 AD liver graft recipients; ethanol use will be the primary outcome variable. This study, conducted in seven Centers, would be executed over five years with a goal of at least seven years treatment exposure. While intent, good will, and patient flow are in place, the consortium Centers unanimously believe that proper organization is not in place and must be developed. Therefore, the group of Centers supports the present proposal for a planning grant that would establish the structures, communications, methods, policies and procedures for the successful completion of a clinical trial specifically designed for AD liver transplant recipients. The present proposal seeks to create among the Centers 1) an organizational structure, 2) a shared theoretical framework, 3) mutually agreed upon treatment and control protocols 4) detailed logistical planning for the protocols, 5) reliable measures of ethanol use, 6) effective communications, data transfer and analysis capabilities and 7) an external review panel of experts. On completion of these tasks, the PI and consortium members expect to have in place not only a well constructed proposal but a demonstrably active, well functioning clinical research consortium capable of executing the proposed clinical trial.

酒精依赖（AD）患者的肝移植仍然是有争议的医学问题。尽管收集了三年的数据现任 PI 和同事表现出独特的高戒酒率在这个经过严格挑选的人群中，移植后任何饮酒行为高达35-40%。虽然酒精率与移植后死亡率，例如酒精性肝病造成的死亡率 (ALD)，保持在约 1-5% 的低水平，任何因 AD 组再次摄入乙醇在医学上是可以预防的这是不可接受的，并且对为 ALD 进行肝移植构成威胁。这上面引用的结果数字表明了两个现象：1）AD 的极限确保长期禁欲的患者选择，以及 2) 的需要针对这一自然禁欲的独特人群的特殊治疗发生率远远超过非移植 AD 病例。更远，纵向数据表明 3) 发生了与酒精相关的死亡移植后第一年之后，所谓的晚期死亡。一个清晰的需要针对这种独特的情况设计和实施有效的治疗方法考虑到他们已经高度戒断的临床人群酒精复发和晚期风险增加的比率及其过程因复发性 ALD 或其他 AD 相关损伤而死亡。肝移植中心联盟提议设计和提出一项有针对性的、积极的、长期的随机临床试验 205 名 AD 肝移植受者测试组的后续护理与 205 AD 肝移植对照组的标准护理相比收件人；乙醇的使用将是主要结果变量。这在七个中心进行的研究将在五年内进行目标是至少接受七年的治疗。虽然有意为之，善意、患者流程到位，财团中心一致认为适当的组织尚未到位，必须得到开发。因此，中心小组支持目前的提议：规划赠款将建立结构、通讯、成功完成任务的方法、政策和程序专为 AD 肝移植受者设计的临床试验。本提案旨在在各中心之间建立 1) 组织结构，2）共享的理论框架，3）相互商定治疗和控制方案 4) 详细的后勤规划协议，5) 可靠的乙醇使用措施，6) 有效的通信、数据传输和分析能力以及 7) 外部专家评审小组。完成这些任务后， PI 和财团成员期望不仅有一口井构建的提案，但显然是积极的、运作良好的能够执行拟议临床的临床研究联盟审判。