Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Number of Participants With Occurrence of First Partial Occlusion (Blockage)
研究概览
简要总结
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.
详细描述
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Able to read and understand English
- •Has a BioFlo implanted port in place less than one (1) year
- •Evidence of a patent BioFlo port catheter prior to enrollment in the study
- •Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo implanted port
- •Current treatment protocol projected to continue for a minimum of three (3) months
- •Anticipates receiving care at the identified centers for 12 months following enrollment in the study
- •Does not receive care of BioFlo implanted port at any other facility
排除标准
- •Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin
- •Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)
- •Does not meet one or more of the inclusion criteria
研究组 & 干预措施
Control Group
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
干预措施: Heparinized saline catheter flush (Other)
Intervention Group
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
干预措施: Saline-only catheter flush (Drug)
结局指标
主要结局
Number of Participants With Occurrence of First Partial Occlusion (Blockage)
时间窗: baseline to 1 year
Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded.
Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion
时间窗: baseline to 1 year
Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded.
Number of Participants With Occurrence of First Complete Occlusion (Blockage)
时间窗: baseline to 1 year
Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.
次要结局
- Number of Complete or Partial Occlusions(baseline to 1 year)
- Number of Days Catheter Remains Patent (Unobstructed)(baseline to 1 year)
- Heparin-related Complication(baseline to 1 year)
- Central Line-Associated Blood Stream Infection (CLABSI)(baseline to 1 year)