Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The occurence of catheter related venous thrombosis
研究概览
简要总结
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cancer treatment with need for central venous access
- •Age >18 yrs
- •Suspected survival > 4 weeks
- •Need of central venous access >4 weeks
排除标准
- •Ongoing uncontrolled systemic infection
- •Prescence of significant thrombosis/stenosis in arm or central veins
- •Unability to communicate
- •Probable upcoming need for dialysis fistula
研究组 & 干预措施
PICC-line
PICC line insertion.
干预措施: PICC or subcutaneous venous port (Device)
PORT
Subcutaneous venous port insertion
干预措施: PICC or subcutaneous venous port (Device)
结局指标
主要结局
The occurence of catheter related venous thrombosis
时间窗: Upon clinical suspiscion during the one the patient i enrolled in the study
regular follow-ups at month 1, 3, 6 and 12.
次要结局
未报告次要终点
研究者
Knut Taxbro
MD Consultant in Anesthesia and Intensive Care
Linkoeping University