NCT02165761终止不适用
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.
W.L.Gore & Associates4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
研究概览
简要总结
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is not a candidate for a native fistula.
- •The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
- •The patient has been on hemodialysis for ≥1 month.
排除标准
- •The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
- •The patient has a known hypercoagulable disorder or bleeding disorder.
- •The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.
研究组 & 干预措施
GORE® Hybrid Vascular Graft
Active Comparator
GORE® Hybrid Vascular Graft
干预措施: GORE® Hybrid Vascular Graft (Device)
Non-heparin bonded synthetic graft
Other
Non-heparin bonded synthetic graft
干预措施: Non-heparin bonded synthetic graft (Device)
结局指标
主要结局
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
时间窗: 14 days after index procedure
Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.
次要结局
未报告次要终点
研究者
研究点 (4)
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