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Active, Not Recruiting

NCT Number: NCT05454189

Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Maintenance of Implanted Port Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System - Albert Lea, Albert Lea, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Allergy to heparin
  • Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Treatment and study plan

Reduced IPD Flush Schedule

Device

IPD flush every 12 weeks

Standard IPD Flush Schedule

Device

IPD flush every 4 weeks

Primary outcomes

  1. Rate of IPD patency

    Time frame: 12 weeks post randomization

    IPD patency without major complication

Secondary outcomes

  1. Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.

    Time frame: Up to 48 weeks post randomization

    Rate of IPD patency during long term follow-up

  2. Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.

    Time frame: Up to 48 weeks post randomization

    Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events

  3. Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes

    Time frame: Up to 48 weeks post randomization

    Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status.

  4. Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes

    Time frame: Up to 48 weeks post randomization

    Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale.

  5. Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.

    Time frame: Up to 48 weeks post randomization

    Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events

Sponsors and collaborators

Lead sponsor

Essentia Health

Other

Collaborators

  • Minnesota Cancer Clinical Trials Network

Registry information

Official study title

A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2022
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.