Extended Flushing Interval for Implanted Port Device Maintenance

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen by Bret E. Friday

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Essentia Health

Disqualifiers: Allergy to heparin, pregnant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

How does the extended flushing interval for implanted port device maintenance differ from other treatments?

This treatment is unique because it explores extending the interval between maintenance flushes of implanted ports from the standard 4 weeks to up to 12 weeks, which could reduce the frequency of hospital visits without increasing complications. ^{1 2 3 4 5}

Research Team

Bret E. Friday

Principal Investigator

Essentia Health

Eligibility Criteria

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.

Ability to read and speak English

Exclusion Criteria

You are allergic to heparin.

Vulnerable populations: pregnant women, prisoners, mentally handicapped

Trial Timeline

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

Treatment Details

Interventions

• Reduced IPD Flush Schedule (Procedure)
• Standard IPD Flush Schedule (Procedure)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Interval between port catheter flushing can be extended to four months. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Is There a Relationship Between Frequency of Port-Care Maintenance and Related Complications in Patients With Cancer? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Safety of Extending Implanted Vascular Access Device Maintenance Flush Frequency. [2023]