Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Upper Extremity CR-UEVT
研究概览
简要总结
Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Although PICCs provide a great option for some patients, these catheters have known complications including catheter-related bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high cost. Midline catheters represent a potentially attractive alternative to PICCs for peripheral infusions. As midlines have increased in popularity and new midlines have been introduced into the market, it is necessary to better understand complication profiles of various midline catheters, as it is likely that all catheters are not created equal. Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some midline catheters are coated to provide protection against catheter-related venous thrombosis and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters need further validation in human subjects.
详细描述
Study Design
The investigators propose a prospective single-site, parallel, two-arm, randomized investigation to assess catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.
Research staff of Beaumont Health Institute will allocate two midline catheters to eligible participants according to a pre-generated randomized list at a 1:1 ratio in block randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline catheters. Participant enrollment will take place from November 2018 until recruitment of 250 participants, 125 in each group, is complete. Demographic and health-related information will be obtained from electronic medical records during enrolled period at William Beaumont Hospital.
Practitioner Participation/Training
Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus are eligible to place catheters for this study. All investigators are credentialed in placing PICCs and midlines by institutional policy and have greater than one year of experience in these procedures.
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
- •All inpatients 18 years of age and older
- •Inpatients that require midline catheter placement by the bedside vascular access team
排除标准
- •Do not meet inclusion criteria
- •Multiple lumens required
- •Alternative diameter of catheter used
- •If already enrolled once prior
- •Withdraw voluntarily from the study
- •Actively (within 24 hours) taking a therapeutic dose of an anticoagulant (heparin, low molecular weight heparin, enoxaparin, rivaroxaban, apixaban, dabigatran, edoxaban, warfarin, arixtra, factor Xa inhibitors)
- •Receiving a midline catheter for anticoagulant therapy
结局指标
主要结局
Upper Extremity CR-UEVT
时间窗: 30 days post line insertion
Number of participants with proven sonographic diagnosis of DVT and/or SVT
次要结局
- Line Related Infection(30 days post line insertion)
研究者
Amit Bahl
Director, Emergency Ultrasound
William Beaumont Hospitals