Extended Flushing Interval for Implanted Port Device Maintenance

Recruiting at 16 trial locations

Overseen By Tammie Mlodozyniec

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Essentia Health

Disqualifiers: Allergy to heparin, pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of flushing implanted port devices every 12 weeks instead of the usual 4 weeks. The goal is to determine if patients can reduce maintenance visits without increasing risks. Participants are divided into two groups: one follows the regular 4-week flush schedule (Standard IPD Flush Schedule), and the other follows the new 12-week schedule (Reduced IPD Flush Schedule). Suitable candidates are those currently undergoing cancer treatment with an implanted port device who do not need their port accessed for 12 weeks beyond routine flushing. As an unphased trial, this study offers an opportunity to contribute to research that could simplify port maintenance for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this extended flushing interval for implanted port devices is safe?

Research has shown that extending the time between cleaning implanted port devices (IPDs) from 4 weeks to 12 weeks is generally safe. One study found that about 37% of these devices were removed, with similar rates across different groups: 25% in one group, 30% in another, and 26% in the third. These results indicate that the longer interval between cleanings did not lead to more removals than usual. Overall, the findings suggest that extending the time between cleanings could be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether implanted port devices (IPDs) can be maintained with less frequent flushing, potentially improving patient comfort and convenience. The standard care for IPDs typically requires flushing every 4 weeks to prevent blockages and infections. This trial tests a new approach, extending the interval to 12 weeks. If successful, this could reduce the frequency of hospital visits, help lower healthcare costs, and simplify life for patients who rely on these devices.

What evidence suggests that this trial's flushing schedules could be effective?

This trial will compare two different flushing schedules for implanted port devices (IPDs). Research has shown that flushing IPDs every 12 weeks, which participants in one arm of this trial will receive, is as safe and effective as the usual 4-week schedule, followed by participants in the other arm. One study found that flushing every three months did not lead to more port removals compared to more frequent flushing. The rates of removal were similar regardless of flushing frequency, with no major differences in safety or effectiveness. This suggests that a longer interval might effectively maintain IPDs without risking patient safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Bret E. Friday

Principal Investigator

Essentia Health

Are You a Good Fit for This Trial?

This trial is for adult hematology/oncology patients with an implanted port device (IPD) used for chemotherapy, who haven't had complications like Deep Vein Thrombosis in the last 4 weeks. Participants should not need to use their IPD outside of routine flushing for the next 12 weeks and must be able to give informed consent and understand English.

Inclusion Criteria

I haven't had a serious blood clot or major issues with an implanted port in the last 4 weeks.

I haven't had a serious blood clot or major issues with an implanted port in the last 4 weeks.

No planned clinical visits for at least 12 weeks

Exclusion Criteria

You are allergic to heparin.

Vulnerable populations: pregnant women, prisoners, mentally handicapped

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12-week interval

12 weeks

3 visits (in-person) for 4-week group, 1 visit (in-person) for 12-week group

Continuation

Participants may 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

36 weeks

9 visits (in-person) for 4-week group, 3 visits (in-person) for 12-week group

Follow-up

Participants are monitored for long-term rate of IPD patency and other outcomes up to 48 weeks post-randomization

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reduced IPD Flush Schedule
• Standard IPD Flush Schedule

Trial Overview The study is testing if it's safe to extend the routine flushing of implanted port devices from every 4 weeks to every 12 weeks. This could potentially make maintenance easier without compromising safety or effectiveness.

How Is the Trial Designed?

Group I: 12-week IPD Flushing Schedule Experimental Treatment 1 Intervention

IPD standard maintenance flushes and port assessments every 12 weeks.

Group II: 4-week IPD Flushing Schedule Active Control 1 Intervention

IPD standard maintenance flushes and port assessments every 4 weeks.

Who Is Running the Clinical Trial?

Essentia Health

Lead Sponsor

Trials

27

Recruited

107,000+

Minnesota Cancer Clinical Trials Network

Collaborator

Trials

1

Recruited

400+

Published Research Related to This Trial

In a phase II study involving 87 oncologic patients, extending the maintenance flushing interval of implanted ports from once a month to once every 3 months resulted in a low rate of port-related complications (11.49%), with no infections or symptomatic thrombosis reported.

The study suggests that this extended flushing schedule is safe and effective, potentially improving patient adherence and satisfaction while also reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. Diaz, JA., Rai, SN., Wu, X., et al.[2018]

In a study of 59 patients with implanted vascular access devices (IVADs), 25% showed visible clots and abnormal appearances in the blood when aspirated after 8 to 17+ weeks without flushing, indicating potential risks associated with extended flushing intervals.

The findings suggest that while guidelines may allow for flushing every 12 weeks, there is a need for further research to determine the optimal maintenance frequency for IVADs to ensure patient safety and device functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Extending Implanted Vascular Access Device Maintenance Flush Frequency. McManus, M., Sarver, MJ., Ser, E., et al.[2023]

Recent studies suggest that the optimal flushing interval for totally implantable access devices (TIVADs) may need to be extended beyond the commonly recommended 4 weeks, with some advocating for intervals of up to 8 weeks.

A meta-analysis by Wu et al. supports this change, indicating that current guidelines may require a revision to improve flushing techniques and methods, highlighting the need for updated recommendations from the scientific community and device manufacturers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending the interval of flushing procedures of totally implantable vascular access devices in cancer patients: It is time for a change. Bertoglio, S.[2021]

A study involving 1,059 oncology and hematology patients demonstrated that extending the interval between maintenance port flushes from the recommended monthly schedule to every 12 weeks is medically safe.

There was no significant increase in port-related complications, such as infections or malfunctions, when comparing patients with flush intervals of 4-8 weeks to those with 12-week intervals, indicating that less frequent flushes can be safely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Relationship Between Frequency of Port-Care Maintenance and Related Complications in Patients With Cancer? Lang, T., Jaboury, S., West, A., et al.[2022]

A study of 349 patients with totally implantable access ports found that flushing these ports every 4 months instead of every 4 weeks is safe and does not increase complications, with only 4.6% experiencing issues.

Extending the flushing interval significantly reduces healthcare costs while maintaining patient safety, suggesting that current manufacturer guidelines may be overly conservative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interval between port catheter flushing can be extended to four months. Ignatov, A., Ignatov, T., Taran, A., et al.[2010]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05454189?term=caustic&checkSpell=&rank=8

Safety of Extending The Routine Flushing Of Implanted ... 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.

2. withpower.com withpower.com/trial/phase-flushing-7-2022-ba883

Extended Flushing Interval for Implanted Port Device ... 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05454189/safety-of-extending-the-routine-flushing-of-implanted-port-devices-from-4-weeks-to-12

Safety of Extending The Routine Flushing Of Implanted ... 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28084883/

Phase II Trial on Extending the Maintenance Flushing ... Conclusion: Extending the maintenance flushes of implanted ports in adult oncologic patients to once every 3 months is safe, effective, and likely to increase ...

5. cancernursingtoday.com cancernursingtoday.com/post/extended-port-flush-maintenance-schedule-safe

Extended Port Flush Maintenance Schedule Safe Overall, 37% of ports were removed. The percentages removed were comparable between the three cohorts: 25% in cohort 1, 30% in cohort 2 and 26% ...

6. clinicaltrial.be clinicaltrial.be/en/details/16114?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety of Extending The Routine Flushing Of Implanted Por... IPD standard maintenance flushes and port assessments every 12 weeks. Interventions:Device: Reduced IPD Flush Schedule. Primary outcomes 1 ...