COLLABORATIVE CLINICAL TRIALS IN VASCULAR ACCESS

血管通路的协作临床试验

• 批准号: 7131291
• 负责人: BRADLEY S DIXON
• 金额: $ 15.31万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7131291
• 关键词: arteriovenous shunt surgery; artery stenosis; aspirin; chemoprevention; chronic renal failure; clinical research; clinical trial phase III; clopidogrel; cooperative study; dipyridamole; hemodialysis; hemodynamics; human subject; human therapy evaluation; hyperplasia; longitudinal human study; patient oriented research; placebos; statistics /biometry; therapy adverse effect; thrombosis

DESCRIPTION (provided by applicant): Access to the circulation is essential to provide hemodialysis treatment to people with ESRD. However, vascular access failure is a major cause of morbidity and expense in care of these patients. An established arteriovenous fistula is the recommended access due to longer survival and fewer complications compared to a graft. Unfortunately early fistula thrombosis occurs frequently and many fistulas do not develop adequately to support hemodialysis. If a fistula cannot be established, an arteriovenous graft is used. Although grafts can be used earlier, over half will fail within a year of placement. The cause of graft failure is neointimal hyperplasia leading to stenosis and thrombosis. To address these problems the Dialysis Access Consortium (DAC) designed and initiated two separate trials: one for fistulas and the other for grafts. The fistula trial entitled, "Clopidogrel Prevention of Early AV Fistula Thrombosis," is a randomized double-blind placebo controlled trial to determine if 6-weeks of clopidogrel given at the time of access placement increases the patency rate of newly placed fistulas. A secondary aim is to determine if clopidogrel increases the number of fistulas that are suitable for dialysis. A sample size of 1284 provides 85% power to detect a 30% reduction in the primary endpoint, 6-week fistula patency. The graft trial entitled "Aggrenox Prevention of Access Stenosis," is a randomized double-blind placebo controlled trial to determine if dipyridamole given in the form of Aggrenox (which also contains a small amount of aspirin) can prevent access stenosis and prolong primary unassisted patency in newly constructed grafts. Monthly measurement of access flow rate is done to detect hemodynamically significant stenosis before the graft clots. A sample size of 1056 provides 85% power to detect a 25% reduction in the primary endpoint, primary unassisted patency. Enrollment into both trials began in January 2003 and is scheduled to end in early 2007. Data is collated and analyzed at the Data Coordinating Center at the Cleveland Clinic. An external advisory committee monitors safety and efficacy. The present proposal seeks to continue participation by the University of lowa-affliated Eastern Iowa Western Illinois Vascular Access Consortium in collaboration with the DAC to successfully complete these two important trials. If the treatments are proven to be beneficial, they will substantially reduce the morbidity and possibly the overall cost of providing care to hemodialysis patients.

描述（由申请人提供）：进入循环对于向ESRD患者提供血液透析治疗至关重要。然而，血管通路失败是这些患者的发病率和护理费用的主要原因。与移植物相比，建立的动静脉瘘是推荐的入路，因为其存活时间更长，并发症更少。不幸的是，早期瘘血栓形成经常发生，许多瘘没有充分发展，以支持血液透析。如果不能建立瘘，则使用动静脉移植物。虽然移植物可以更早使用，但超过一半的移植物会在一年内失败。移植失败的原因是新生内膜增生导致狭窄和血栓形成。为了解决这些问题，透析通路联盟（DAC）设计并启动了两项单独的试验：一项针对瘘管，另一项针对移植物。名为“氯吡格雷预防早期动静脉瘘血栓形成”的瘘试验是一项随机、双盲、安慰剂对照试验，旨在确定在入路放置时给予6周氯吡格雷是否会增加新放置瘘的通畅率。第二个目的是确定氯吡格雷是否会增加适合透析的瘘管数量。1284例样本量提供了85%的把握度，可检测到主要终点（6周瘘管通畅率）降低30%。名为“艾诺思预防动脉狭窄”的移植试验是一项随机双盲安慰剂对照试验，旨在确定以艾诺思（也含有少量阿司匹林）形式给予的双嘧达莫是否可以预防新构建移植物的动脉狭窄并延长主要无辅助通畅率。每月测量一次入路流速，以在移植物凝块前检测血流动力学显著狭窄。1056例样本量提供了85%的把握度来检测主要终点（主要无辅助通畅率）降低25%。两项试验的招募工作于2003年1月开始，计划于2007年初结束。数据在克利夫兰诊所的数据协调中心进行整理和分析。外部咨询委员会监测安全性和有效性。本提案旨在继续参与与洛瓦大学有关联的东爱荷华州西伊利诺伊州血管通路联盟与DAC合作，以成功完成这两项重要试验。如果治疗被证明是有益的，它们将大大降低发病率，并可能降低为血液透析患者提供护理的总成本。

项目成果

Monthly access flow monitoring with increased prophylactic angioplasty did not improve fistula patency.

每月进行的通路流量监测并增加预防性血管成形术并不能改善瘘管通畅。

• DOI: 10.1111/j.1523-1755.2005.00697.x
• 发表时间: 2005
• 期刊: Kidney international
• 影响因子: 19.6
• 作者: Shahin,Hassan;Reddy,Geeta;Sharafuddin,Melhem;Katz,Daniel;Franzwa,BradleyS;Dixon,BradleyS
• 通讯作者: Dixon,BradleyS

Early fistula failure: back to basics.

• DOI: 10.1053/j.ajkd.2007.09.006
• 发表时间: 2007-11
• 期刊: American journal of kidney diseases : the official journal of the National Kidney Foundation
• 作者: L. Dember;B. Dixon