HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM

这是杜克大学医学中心医学部、肾脏和血液科以及外科的一份申请，申请作为临床中心参加由NIH赞助的血液透析血管通路临床试验联盟。这项拟议的试验是对一系列新药进行的随机前瞻性评估，这些新药如ElmIron(注册商标)戊聚糖多磺酸盐钠见附录A，或组织因子途径抑制物TFPI见附录A或其他新型干预剂)与安慰剂在预防血液透析血管通路狭窄和血液透析AV通路中血栓形成方面的对比。患者将随机接受ElmIron(R)(或其他试验药物)和安慰剂的治疗。随机化标准将包括这是第一次还是随后的房室移植物，以及移植物的位置和是否有糖尿病。所有进入这项研究的患者都将接受由超声稀释技术确定的AV通路流量的筛查。初始流量低于1000毫升/分钟的移植物将不会被随机分配。患者将被前瞻性地跟踪每月通过超声稀释测量血液透析血管通路的流量。房室血流量减少超过25%将促使静脉造影进行评估。这项研究的主要终点将是双平面静脉造影术确定的狭窄程度超过50%，同时伴有血流减少。所有ACCESS血栓形成的发作也将作为主要终点。次要终点将包括所有其他动静脉管通路并发症和住院治疗。辅助性研究将包括动静脉曲张对介入的反应，通路通畅性，以及研究中安慰剂和干预药物的成本。

This is an application from the Department of Medicine, Divisions of Nephrology and Hematology, and the Department of Surgery at the Duke University Medical Center to participate as a clinical center in the NIH- sponsored Hemodialysis Vascular Access Clinical Trials Consortium. The proposed trial is a randomized prospective evaluation of a series of novel agents such as (Elmiron(R) pentosan polsulfonate sodium see appendix A, or Tissue Factor Pathway Inhibitor TFPI see appendix A or other novel interventional agent) versus placebo in the prevention of hemodialysis vascular access stenosis and thrombosis in hemodialysis AV access. Patients will be randomized to therapy with Elmiron(R) (or other trial agent) versus placebo. Randomization criteria will include whether this is a first or a subsequent AV graft as well as graft location and the presence or absence of diabetes mellitus. All patients entering the study will be screened with AV access flow, determined by the ultrasound dilution technique. Grafts with initial flows less than 1000 ml/min will not be randomized. Patients will be prospectively followed with monthly measurements of hemodialysis vascular access flow by ultrasound dilution. Decrements in AV access flow greater than 25% will prompt evaluation by venography. The primary end point in the study will be the development of a greater than 50% stenosis as determined by biplanar venography when associated with a concurrent flow decrement. All episodes of Access thrombosis will also serve as primary endpoints. Secondary end points will include all other AV access complications and hospitalizations. Ancillary studies will include response of AV access to intervention, access patency, and the cost of the placebo and intervention arms of the study.