NCT03109574已完成不适用
A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 6
- 主要终点
- Resource utilization related to hemodialysis catheter placement - tPA
研究概览
简要总结
This is a prospective, multi-center health economic study in Canada. Participants will be randomly assigned to receive either the study or control dialysis catheter. The primary objective is to evaluate resource utilization in Ontario related to hemodialysis catheter placement including tissue plasminogen activator (tPA) usage, catheter exchange rates, catheter patency, and missed dialysis days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Is indicated for a dialysis catheter for the purpose of attaining long-term vascular access for hemodialysis. Long-term vascular access is defined by physician anticipated duration of hemodialysis for three months or longer.
- •Is ≥ 18 years of age.
- •Is indicated to receive dialysis treatment at a location where dialysis treatment data will be accessible by the study team.
- •Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study.
排除标准
- •Has known or suspected presence of other device-related infection, bacteremia, or septicemia or has been treated with antibiotics for documented or suspected infection within prior 45 days.
- •Is receiving prophylactic anti-coagulation or anti-platelet pharmacotherapy for the purpose of central venous catheter (CVC) patency (anti-coagulation or anti-platelet pharmacotherapy for therapeutic indications do not exclude the patient from the study).
- •Has severe chronic obstructive lung disease.
- •Had past radiation therapy at the prospective insertion site.
- •Had previous episodes of venous thrombosis or vascular surgical procedures at the prospective insertion site.
- •Has local tissue factors that will prevent proper device stabilization and/or access.
- •Has a stent placed in the vessel where the catheter will be placed
- •Is pregnant
- •History of drug or alcohol abuse in the past 12 months obtained from patient record and/or interview
- •Subjects who weigh ≤ 30 kg.
- •Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.
结局指标
主要结局
Resource utilization related to hemodialysis catheter placement - tPA
时间窗: 1 year
vials of tPA utilized (unit)
次要结局
- Incidence of catheter-related complications(1 year)
研究者
Dr. Sandra Donnelly
Clinical Nephrologist
William Osler Health System
研究点 (6)
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