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

December 29, 2023 updated by: Essentia Health

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Recruiting
        • Mayo Clinic Health System - Albert Lea
        • Contact:
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health St. Joseph's Medical Center
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health Deer River Clinic
        • Contact:
          • Tammie Mlodozyniec
      • Detroit Lakes, Minnesota, United States, 56501
        • Recruiting
        • Essentia Health St Mary's Detroit Lakes Clinic
        • Contact:
          • Tammie Mlodozyniec
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Duluth Clinic
        • Principal Investigator:
          • Bret Friday, MD, PhD
        • Contact:
      • Fosston, Minnesota, United States, 56542
        • Recruiting
        • Essentia Health Fosston
        • Contact:
          • Tammie Mlodozyniec
      • Grand Rapids, Minnesota, United States, 55744
        • Recruiting
        • Fairview Grand Itasca Clinic & Hospital
        • Contact:
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Contact:
          • Tammie Mlodozyniec
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Fairview Range Medical Center
        • Contact:
      • Mankato, Minnesota, United States, 56001
        • Recruiting
        • Mayo Clinic Health System - Mankato
        • Contact:
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
      • Park Rapids, Minnesota, United States, 56470
        • Recruiting
        • Essentia Health Park Rapids
        • Contact:
          • Tammie Mlodozyniec
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
          • Tammie Mlodozyniec
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
          • Tammie Mlodozyniec
      • Worthington, Minnesota, United States, 56187
        • Recruiting
        • Sanford Worthington Medical Center
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Essentia Health Fargo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 4 weeks.
IPD flush every 4 weeks
Experimental: 12-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 12 weeks.
IPD flush every 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of IPD patency
Time Frame: 12 weeks post randomization
IPD patency without major complication
12 weeks post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.
Time Frame: Up to 48 weeks post randomization
Rate of IPD patency during long term follow-up
Up to 48 weeks post randomization
Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
Time Frame: Up to 48 weeks post randomization
Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events
Up to 48 weeks post randomization
Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
Time Frame: Up to 48 weeks post randomization
Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status.
Up to 48 weeks post randomization
Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
Time Frame: Up to 48 weeks post randomization
Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale.
Up to 48 weeks post randomization
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.
Time Frame: Up to 48 weeks post randomization
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events
Up to 48 weeks post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Bret Friday, MD, PhD, Essentia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNCCTN024
  • EH21C1 (Other Identifier: Essentia Health)
  • EH22738 (Other Identifier: Essentia Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol, statistical plan and consent form will be available on request. Data will be available on aggregate level; data will be deidentified, the full dataset and statistical code will be available upon request

IPD Sharing Time Frame

6 months after study completion and for 36 months

IPD Sharing Access Criteria

A full description of the intended use of the data must be sent to the Project Direct for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maintenance of Implanted Port Devices

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