AV SHUNT IMPLANTATION IN HEMODIALYSIS PATIENTS

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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.