NCT03019302Unknown不适用
A Study to Determine the Incidence of Catheter-Related Venous Thrombosis When Using Arrow Peripherally-Inserted Central Catheters With Chlorag+Ard Technology
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Teleflex
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
研究概览
简要总结
A prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. All subjects will receive PICC access using the Arrow PICC with Chloragard Technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater (note: maximum study period is 90 days)
- •Ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of PICC management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary
- •Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study
排除标准
- •Previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter
- •History or diagnosis of peripheral or central vein stenosis (on proposed insertion side)
- •History or diagnosis of veno-occlusive disease
- •History or diagnosis of superior vena cava syndrome
- •Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
- •Previous enrollment in this study
- •Currently pregnant or breast feeding
- •Previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent
- •Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
- •Medical, social, and/or psychological problems precluding subject from study participation
- •Stage 2, 3 or 4 chronic kidney disease or serum creatinine > 3 mg/dl or Glomerular Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a nephrologist for participation
- •Known allergy or sensitivity to chlorhexidine
结局指标
主要结局
Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
时间窗: within maximum 90 days dwell
Incidence of catheter occlusion
时间窗: within maximum 90 days dwell
Incidence of catheter-related bloodstream infections
时间窗: within maximum 90 days dwell
次要结局
未报告次要终点
研究者
研究点 (4)
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