Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
研究概览
简要总结
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
详细描述
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults > 18 yrs old
- •Hemodialysis patients
- •Vascular access with a permanent catheter
- •No prior rt-PA use in the catheter over the previous 21 days
- •One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)
排除标准
- •Critically ill patients in the ICU setting.
- •Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (<48 hours), recent biopsy (<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
- •Hemodialysis catheter has been in the patient less than 14 days.
研究组 & 干预措施
1
Alteplase used by normal dwell procedure
干预措施: alteplase dwell arm (Drug)
2
Alteplase given by an new "push" protocol
干预措施: Alteplase "push" protocol (Drug)
结局指标
主要结局
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
时间窗: 4 hours
次要结局
- Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.(4 hours)
- Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.(72 hours)
- Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.(72 hours)
- Serious adverse events including major bleeding within 24 hours of alteplase administration(30 days post-last dose)