AV SHUNT IMPLANTATION IN HEMODIALYSIS PATIENTS

这是一项安慰剂对照、安全性和有效性剂量发现研究，评估在4组患者中分别给药FFR-rFVIIa和安慰剂对AVG手术放置或置换时AVG 111in -血小板沉积（主要结局）的影响（4:1随机化倾向于积极治疗）。在AVG吻合处积聚111个血小板的成像，以及在随后的队列中不断增加FFR-rFVIIa的剂量，将为接受AVG置放或置换手术的透析患者提供安全性、耐受性和有效的抗血栓剂量方案。该剂量随后将用于AVG衰竭的对照临床试验。我们还建议比较FFR-rFVIIa与安慰剂在术后血栓形成血液测试、止血测试和测量手术出血量方面的剂量反应效应。

This is a placebo-controlled, safety and efficacy dose-finding study assessing the effects of dosing FFR-rFVIIa vs placebo in 4 cohorts of patients each (4:1 randomization favoring active therapy) on AVG 111In-platelet deposition at the time of AVG surgical placement or replacement (primary outcome). Imaging of 111In-platelets accumulating at the sites of AVG anastomoses, and an escalating bolus FFR-rFVIIa in subsequent cohorts will establish safety, tolerance and an effective antithrombotic dose regimen for FFR-rFVIIa administration in dialysis patients undergoing surgical AVG placement or replacement. This dose will subsequently be used in a controlled clinical trial of AVG failure. We also propose to compare the dose-response effects of FFR-rFVIIa vs placebo on post-operative changes in blood tests of thrombosis, tests of hemostasis and measured surgical blood loss.