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

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

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.

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.

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.