AV SHUNT IMPLANTATION IN HEMODIALYSIS PATIENTS

血液透析患者的 AV 分流器植入

• 批准号: 6565714
• 负责人: LAURENCE A HARKER
• 金额: $ 29.31万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6565714
• 关键词: anticoagulants; arteriovenous shunt surgery; blood chemistry; blood disorder chemotherapy; clinical research; contrast media; dosage; drug screening /evaluation; hemodialysis; hemorrhage; hemostasis; human subject; human therapy evaluation; implant; outcomes research; postoperative state; recombinant proteins; thrombosis

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.

这是一项安慰剂对照，安全性和有效性剂量调查研究，评估了在4例患者中给予FFR-RFVIIA vs安慰剂的影响（4：1随机分组（4：1随机分组）对AVG 111in-植物性植物在AVG时的影响手术放置或替代（主要结果）。在AVG吻合的位置积累的111英寸 - 平台的成像，随后的同类群体中不断升级的推注FFR-RFVIIA将建立安全性，耐受性和有效的抗强化剂量为FFR-RFVIIA在糖尿病患者中给药的FFR-RFVIIA治疗方案，该方案在透析患者中​​进行了外径AVG的安排。该剂量随后将用于对AVG衰竭的对照临床试验。我们还建议比较FFR-RFVIIA与安慰剂对血栓形成血液检查后术后变化的剂量反应影响，止血测试和测量的手术失血。