HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM

这是一份来自杜克大学医学中心医学部、肾脏病学和血液学分部以及外科的申请，申请作为临床中心参加NIH申办的血液透析血管通路临床试验联盟。 拟定的试验是一项随机前瞻性评价一系列新型药物，如（Elmiron（R）戊聚糖聚磺酸钠见附录A，或组织因子途径抑制剂TFPI见附录A或其他新型介入药物）与安慰剂相比，预防血液透析血管通路狭窄和血液透析AV通路血栓形成。患者将随机接受Elmiron（R）（或其他试验药物）与安慰剂的治疗。 随机化标准将包括是否为首次或后续AV移植物以及移植物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AV入路血流进行筛选。初始流量小于1000 ml/min的移植物将不会被随机化。通过超声稀释每月测量一次血液透析血管通路流量，对患者进行前瞻性随访。 AV入路血流下降超过25%将提示通过静脉造影进行评价。本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。所有通路血栓形成事件也将作为主要终点。次要终点将包括所有其他AV入路并发症和住院治疗。辅助研究将包括AV通路对干预的反应、通路通畅性以及研究的安慰剂和干预组的成本。

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.