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

Essentia Health

Status: Enrolling

Conditions: Maintenance of Implanted Port Devices

Treatments: Device: Standard IPD Flush Schedule; Device: Reduced IPD Flush Schedule

Study type: Interventional

Funder types: Other

Identifiers

NCT05454189

EH22738 (Other Identifier)

MNCCTN024

EH21C1 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

4-week IPD Flushing Schedule

Active Comparator group

Description:

IPD standard maintenance flushes and port assessments every 4 weeks.

Treatment:

Device: Standard IPD Flush Schedule

12-week IPD Flushing Schedule

Experimental group

Description:

IPD standard maintenance flushes and port assessments every 12 weeks.

Treatment:

Device: Reduced IPD Flush Schedule