A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 34
- 主要终点
- Rate of IPD patency
研究概览
简要总结
Implanted port devices (IPD) play an essential role in the safe administration of cancer treatments by providing a device to safely administer caustic chemotherapy agents. The current recommended frequency of flushing the IPD per manufacturers guidelines is every 4-6 weeks. The purpose of this study is to find out if extending IPD flushes to every 12 weeks is safe and if it is just as effective as every 4 week flushing.
详细描述
After being informed about the study and potential risks, all participants giving written informed consent will complete port specific histories, assessments and questionnaires within 14 days prior to registration. Eligible, consented participants will be registered to the study and randomized to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12 week interval. If study participants agree to the continuation portion of the study, they will continue to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for up to an additional three 12 week cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device.
- •No planned clinical visits for at least 12 weeks.
- •No planned need to access Implanted Port Device within next 12 weeks outside of routine flushing. Potential reasons to access can include but are not limited to lab draw, infusion, IV contrast.
- •No planned removal of IPD within 12 weeks of registration.
- •No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration.
- •Patient Implanted Port Device with documented blood return ≤ 14 days of registration.
- •Ability to read and speak English.
- •Able to give informed consent.
排除标准
- •Allergy to heparin
- •Vulnerable populations: pregnant women, prisoners, mentally handicapped.
研究组 & 干预措施
4-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 4 weeks.
干预措施: Standard IPD Flush Schedule (Device)
12-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 12 weeks.
干预措施: Reduced IPD Flush Schedule (Device)
结局指标
主要结局
Rate of IPD patency
时间窗: 12 weeks post randomization
IPD patency without major complication
次要结局
- Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.(Up to 48 weeks post randomization)
- Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.(Up to 48 weeks post randomization)
- Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes(Up to 48 weeks post randomization)
- Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes(Up to 48 weeks post randomization)
- Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.(Up to 48 weeks post randomization)