A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 10
- 主要终点
- Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
研究概览
简要总结
The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
详细描述
Purpose:
To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2®
Design:
This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema.
Enrollment:
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
- Single (Outcomes Assessor)
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
- •Is indicated for a PICC based on institutional practices
- •Is ≥ 18 years of age
- •Is expected to require use of a PICC for a minimum of 10 days
- •Has normal findings on initial ultrasonography (complete Ultrasound Checklist)
- •Vein used for PICC placement must be a minimum of 5mm in diameter
- •Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study (or has the ICF signed by the patient's legal representative)
排除标准
- •Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters)
- •Has current or anticipated hematologic derangements, including:
- •thrombocytopenia
- •history of heparin-induced thrombocytopenia
- •coagulopathy (International Normalized Ratio 2.5 or greater)
- •established diagnosis of hypercoagulable syndrome (e.g., protein C and S deficiency, anti-phospholipid antibody or polycythemia) or requires systemic therapeutic anticoagulation (Note: The following prophylactic treatments are allowed: subcutaneous heparin or enoxaparin sodium injection, and concomitant use of platelet aggregation inhibitors, e.g., Plavix/Ticlid/aspirin)
- •Has central veno-occlusive disease
- •Has history of previous catheter-related thrombosis
- •Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria):
- •Current (or prior history of) venous thrombosis in all or any portion of the vein where the catheter is expected to reside
- •Conditions that impede venous return from the extremity (such as paralysis or lymphedema after mastectomy)
- •Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
- •Anatomical distortions from surgery, injury or trauma (e.g., orthopedic conditions such as compound fractures requiring reconstructive procedures)
- •Anatomical irregularities (structural, vascular, neurological) which may compromise catheter insertion or catheter care procedures in the involved extremity (e.g., reflex sympathetic dystrophy)
- •Is pregnant or lactating
- •Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
研究组 & 干预措施
BioFlo™ PICC
BioFlo™ Peripherally Inserted Central Catheter (PICC)
干预措施: BioFlo™ Peripherally Inserted Central Catheter (PICC) (Device)
Bard® PowerPICC SOLO2®
Bard® Dual-Lumen PowerPICC SOLO2®
干预措施: Bard® Dual-Lumen PowerPICC SOLO2® (Device)
结局指标
主要结局
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
时间窗: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
次要结局
- Incidence of Other Catheter-related Complications(Up to 30 days post-insertion)