Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Withdrawal occlusion
研究概览
简要总结
Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oncology and hematology patients
- •Life expectancy of minimum of 180 days
排除标准
- •second or femoral long-term central venous access device
- •known allergy to heparin (HIT)
- •coagulation disorders(INR >2, Blood platelets > 1,000,000/mm3)
- •therapeutic intravenous heparin administration
研究组 & 干预措施
Normal saline
In the intervention group the use of heparin as locking solution in the catheter lumen (or lumina) when the catheter is not longer in use is omitted. Catheters are locked under positive pressure with normal saline in stead injecting an extra volume of heparinised saline (100IU/ml).
干预措施: normal saline (Drug)
Heparin lock
干预措施: normal saline (Drug)
结局指标
主要结局
Withdrawal occlusion
时间窗: within180 days
次要结局
- all catheter-related bacteremia(within 180 days)
- Incidence of functional problems other than withdrawal occlusion(within 180 days)