HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM

这是一份来自杜克大学医学中心医学部、肾脏学和血液学分部以及外科部门的申请，申请作为临床中心参与美国国立卫生研究院赞助的血液透析血管通路临床试验联盟。拟议的试验是一项随机前瞻性评估，比较一系列新药(如Elmiron（R)戊聚糖聚磺酸钠（见附录a）或组织因子通路抑制剂TFPI（见附录a）或其他新型介入性药物）与安慰剂在血液透析血管通道狭窄和血栓形成中的预防作用。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AV移植，以及移植的位置和是否存在糖尿病。所有进入研究的患者将通过超声稀释技术确定的房室通路流量进行筛选。初始流量小于1000ml /min的移植物不随机。患者将前瞻性随访，每月通过超声稀释测量血液透析血管通路流量。房室通道流量减少超过25%，需要静脉造影评估。该研究的主要终点将是双平面静脉造影确定的大于50%的狭窄，同时伴有血流减少。通路血栓形成的所有发作也将作为主要终点。次要终点包括所有其他房室通路并发症和住院情况。辅助研究将包括AV进入干预的反应，进入通畅性，以及安慰剂和干预研究组的成本。

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.