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

Last updated: November 15, 2024
Sponsor: Essentia Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hot Flash

Treatment

Reduced IPD Flush Schedule

Standard IPD Flush Schedule

Clinical Study ID

NCT05454189
MNCCTN024
EH22738
EH21C1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 ofroutine flushing. Potential reasons to access can include but are not limited to labdraw, infusion, IV contrast.

  • No planned removal of IPD within 12 weeks of registration.

  • No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4weeks of registration.

  • Patient Implanted Port Device with documented blood return ≤ 14 days ofregistration.

  • Ability to read and speak English.

  • Able to give informed consent.

Exclusion

Exclusion Criteria:

  • Allergy to heparin

  • Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Reduced IPD Flush Schedule
Phase:
Study Start date:
October 11, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Mayo Clinic Health System - Albert Lea

    Albert Lea, Minnesota 56007
    United States

    Active - Recruiting

  • Essentia Health St. Joseph's Medical Center

    Brainerd, Minnesota 56401
    United States

    Active - Recruiting

  • Essentia Health Deer River Clinic

    Deer River, Minnesota 56636
    United States

    Active - Recruiting

  • Essentia Health St Mary's Detroit Lakes Clinic

    Detroit Lakes, Minnesota 56501
    United States

    Active - Recruiting

  • Essentia Health Duluth Clinic

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • Essentia Health Fosston

    Fosston, Minnesota 56542
    United States

    Active - Recruiting

  • Fairview Grand Itasca Clinic & Hospital

    Grand Rapids, Minnesota 55744
    United States

    Active - Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota 55746
    United States

    Active - Recruiting

  • Fairview Range Medical Center

    Hibbing, Minnesota 55746
    United States

    Active - Recruiting

  • Mayo Clinic Health System - Mankato

    Mankato, Minnesota 56001
    United States

    Active - Recruiting

  • Monticello Cancer center

    Monticello, Minnesota 55362
    United States

    Active - Recruiting

  • Essentia Health Park Rapids

    Park Rapids, Minnesota 56470
    United States

    Active - Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota 55371
    United States

    Active - Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota 55072
    United States

    Active - Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesota 55792
    United States

    Active - Recruiting

  • Sanford Worthington Medical Center

    Worthington, Minnesota 56187
    United States

    Active - Recruiting

  • Essentia Health Fargo

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

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