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.

Study Overview

• Status: Recruiting
• Conditions: Maintenance of Implanted Port Devices
• Intervention / Treatment: Device: Standard IPD Flush Schedule; Device: Reduced IPD Flush Schedule

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

• Study Contact: Name: Bret Friday, MD, PhD; Phone Number: 218-786-3625; Email: bret.friday@essentiahealth.org
• Study Contact Backup: Name: Tammie Mlodozyniec; Phone Number: 218-786-1018; Email: tammie.mlodozyniec@essentiahealth.org

Study Locations

• United States
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Recruiting
      • Mayo Clinic Health System - Albert Lea
      • Contact: Mina Hanna, MD; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • 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: Tammie Mlodozyniec; Phone Number: 218-786-1018; Email: tammie.mlodozyniec@essentiahealth.org
    • 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: Anastas Provatas; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • Hibbing, Minnesota, United States, 55746
      • Recruiting
      • Essentia Health Hibbing Clinic
      • Contact: Tammie Mlodozyniec
    • Hibbing, Minnesota, United States, 55746
      • Recruiting
      • Fairview Range Medical Center
      • Contact: Anastas Provatas; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • Mankato, Minnesota, United States, 56001
      • Recruiting
      • Mayo Clinic Health System - Mankato
      • Contact: Stephan Thome; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • Monticello, Minnesota, United States, 55362
      • Recruiting
      • Monticello Cancer Center
      • Contact: Yan Ji, MD; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • 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: Anastas Provatas; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
    • 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: Jonathan Bleeker; Phone Number: 612-624-2620; Email: ccinfo@umn.edu
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • Essentia Health Fargo

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Device: Standard IPD Flush Schedule; IPD flush every 4 weeks
Experimental: 12-week IPD Flushing Schedule; IPD standard maintenance flushes and port assessments every 12 weeks.	Device: Reduced IPD Flush Schedule; IPD flush every 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of IPD patency	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.	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.	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	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	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.	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

• Sponsor: Essentia Health
• Collaborators: Minnesota Cancer Clinical Trials Network
• Investigators: Principal Investigator: Bret Friday, MD, PhD, Essentia Health

Study record dates

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: Skin Manifestations; Flushing
• 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