Maintaining Patency in Implanted Port Catheters With Saline Only Flushes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 8
- 主要终点
- Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
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 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 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
- 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
- •Able to read and understand English
- •Has an implanted port in place less than one (1) year
- •Evidence of a patent (unobstructed) port catheter prior to enrollment in the study
- •Is receiving active treatment (i.e., receiving a therapeutic drug through the 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 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 have a BioFlo port (heparinized port)
- •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 (Other)
结局指标
主要结局
Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
时间窗: baseline to 1 year
Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year
Number of Participants With First Complete Occlusion Within 1 Year
时间窗: baseline to 1 year
Number of participants who had a first complete occlusion (Blockage) within 1 year
Number of Participants With First Partial Occlusion Within 1 Year
时间窗: baseline to 1 year
Number of Participants with First Partial Occlusion (Blockage) within 1 year
次要结局
- Number of Participants With HIT Within 1 Year(baseline to 1 year)
- Number of Participants With First Complete or Partial Occlusion Within 1 Year(baseline to 1 year)