A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.
研究概览
简要总结
This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.
详细描述
Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Newly placed double-lumen hemodialysis catheter
排除标准
- •Major bleed within last 3 months
- •Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR > 1.5, not due to warfarin)
- •Active peptic ulcer disease
- •Anticipated need for invasive intervention within next 2 weeks
- •Taking warfarin for an indication other than access prophylaxis
- •Allergic to, or intolerant of, warfarin
- •Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
- •Catheter likely needed for 2 weeks or less
- •Patient previously took part in the study
- •Patient has known aortic aneurysm of 6cm or greater
- •Patients nephrologist has refused consent
- •Patient has refused consent
研究组 & 干预措施
1
Receiving warfarin
干预措施: warfarin (Drug)
2
Receiving matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.
时间窗: monthly
次要结局
- Death from any cause.(monthly)
- Major bleeding events.(monthly)
- Blood flow rate and adequacy of dialysis.(monthly)