NCT00728819已完成不适用
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Evidence of PICC-related Venous Thrombosis
研究概览
简要总结
The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of > 2 weeks
- •Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative
排除标准
- •Skin related problems around the insertion site (infection, phlebitis, scars)
- •History of mastectomy/axillary dissection on insertion side
- •Coagulopathy with an INR of > 2.0
- •Thrombocytopenia with platelets < 25,000 uL
- •Renal insufficiency with a creatinine of > 3.0 mg/dL
- •Documented current upper extremity or central venous thrombosis
- •Hypercoagulable states (protein C or S deficiency, AT-III deficiency, lupus anticoagulant)
- •Catheters needed for therapy within less than an hour (emergent placement not allowing sufficient time for proper research consent and randomization)
- •Patient has already been enrolled in this research study
- •Life expectancy less than 1 month
研究组 & 干预措施
1
Active Comparator
Tapered PICC
干预措施: Tapered PICC (Device)
1
Active Comparator
Tapered PICC
干预措施: Non-tapered PICC (Device)
2
Active Comparator
Non-tapered PICC
干预措施: Non-tapered PICC (Device)
结局指标
主要结局
Evidence of PICC-related Venous Thrombosis
时间窗: 28 days, PICC removal or hospital discharge
Number participants with vein thrombosis
次要结局
- Symptomatic PICC-related Venous Thrombosis(Procedure through 28 days)
- Post-operative Bleeding(Day 1)
研究者
研究点 (2)
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