Testing if flushing implanted port devices every 12 weeks is safe and effective.

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

This study is testing if flushing implanted port devices every 12 weeks is safe and effective for people who use them.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Essentia Health (other)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Albert Lea, Minnesota and 16 other locations)
• Trial ID: NCT05454189 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of extending the flushing schedule of implanted port devices (IPDs) from the standard 4 weeks to 12 weeks. Participants will be randomly assigned to receive either the standard flushing schedule or the extended schedule for an initial 12-week period, with the option to continue for additional cycles. The study aims to determine if less frequent flushing can maintain the functionality of the IPDs while ensuring patient safety. Participants will complete assessments and questionnaires to monitor their health and the condition of their IPDs throughout the study.

Who should consider this trial

Good fit: Ideal candidates are hematology/oncology patients aged 18 and older with an implanted port device who do not require access to the device for at least 12 weeks.

Not a fit: Patients with recent complications related to their implanted port device or those who require frequent access to the device may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce the frequency of medical visits for patients, improving their quality of life while maintaining the safety of their treatment.

How similar studies have performed: While the approach of extending flushing intervals is novel, similar studies have not been widely conducted, making this an exploratory investigation.

Eligibility criteria

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.

Where this trial is running

Albert Lea, Minnesota and 16 other locations

• Mayo Clinic Health System - Albert Lea — Albert Lea, Minnesota, United States (RECRUITING)
• Essentia Health St. Joseph's Medical Center — Brainerd, Minnesota, United States (RECRUITING)
• Essentia Health Deer River Clinic — Deer River, Minnesota, United States (RECRUITING)
• Essentia Health St Mary's Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States (RECRUITING)
• Essentia Health Duluth Clinic — Duluth, Minnesota, United States (RECRUITING)
• Essentia Health Fosston — Fosston, Minnesota, United States (RECRUITING)
• Fairview Grand Itasca Clinic & Hospital — Grand Rapids, Minnesota, United States (RECRUITING)
• Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States (RECRUITING)
• Fairview Range Medical Center — Hibbing, Minnesota, United States (RECRUITING)
• Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (RECRUITING)
• Monticello Cancer center — Monticello, Minnesota, United States (RECRUITING)
• Essentia Health Park Rapids — Park Rapids, Minnesota, United States (RECRUITING)
• Fairview Northland Medical Center — Princeton, Minnesota, United States (RECRUITING)
• Essentia Health Sandstone — Sandstone, Minnesota, United States (RECRUITING)
• Essentia Health Virginia Clinic — Virginia, Minnesota, United States (RECRUITING)
• Sanford Worthington Medical Center — Worthington, Minnesota, United States (RECRUITING)
• Essentia Health Fargo — Fargo, North Dakota, United States (RECRUITING)

Study contacts

• Principal investigator: Bret Friday, MD, PhD — Essentia Health
• Study coordinator: Bret Friday, MD, PhD

Conditions: Maintenance of Implanted Port Devices