RecruitingNot ApplicableNCT05454189

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


Sponsor

Essentia Health

Enrollment

400 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria2

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEReduced IPD Flush Schedule

IPD flush every 12 weeks

DEVICEStandard IPD Flush Schedule

IPD flush every 4 weeks


Locations(17)

Mayo Clinic Health System - Albert Lea

Albert Lea, Minnesota, United States

Essentia Health St. Joseph's Medical Center

Brainerd, Minnesota, United States

Essentia Health Deer River Clinic

Deer River, Minnesota, United States

Essentia Health St Mary's Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Essentia Health Duluth Clinic

Duluth, Minnesota, United States

Essentia Health Fosston

Fosston, Minnesota, United States

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Fairview Range Medical Center

Hibbing, Minnesota, United States

Mayo Clinic Health System - Mankato

Mankato, Minnesota, United States

Monticello Cancer center

Monticello, Minnesota, United States

Essentia Health Park Rapids

Park Rapids, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Sanford Worthington Medical Center

Worthington, Minnesota, United States

Essentia Health Fargo

Fargo, North Dakota, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05454189