AV SHUNT IMPLANTATION IN HEMODIALYSIS PATIENTS

这是一项安慰剂对照、安全和有效的剂量发现研究，评估了在AVG手术放置或替换时(主要结果)，在4组患者中，剂量FFR-rFVIIa与安慰剂(4：1随机赞成积极治疗)对AVG 111In血小板沉积的影响。对AVG吻合部位聚集的111In-血小板进行成像，并在随后的队列中逐步增加FFR-rFVIIa剂量，将为接受外科AVG放置或置换的透析患者提供安全、耐受和有效的抗血栓剂量方案。该剂量随后将用于AVG失败的对照临床试验。我们还建议比较FFR-rFVIIa与安慰剂在术后血栓形成、止血试验和测量的手术失血量方面的剂量-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.