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Trial record 1 of 1 for:    A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks
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Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05454189
Recruitment Status : Recruiting
First Posted : July 12, 2022
Last Update Posted : January 10, 2023
Sponsor:
Collaborator:
Minnesota Cancer Clinical Trials Network
Information provided by (Responsible Party):
Essentia Health

Brief 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.

Condition or disease Intervention/treatment Phase
Maintenance of Implanted Port Devices Device: Reduced IPD Flush Schedule Device: Standard IPD Flush Schedule Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in participants on an IPD maintenance flush schedule.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks
Actual Study Start Date : October 11, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

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




Primary Outcome Measures :
  1. Rate of IPD patency [ Time Frame: 12 weeks post randomization ]
    IPD patency without major complication


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05454189


Contacts
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Contact: Bret Friday, MD, PhD 218-786-3625 bret.friday@essentiahealth.org
Contact: Tammie Mlodozyniec 218-786-1018 tammie.mlodozyniec@essentiahealth.org

Locations
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United States, Minnesota
Mayo Clinic Health System - Albert Lea Recruiting
Albert Lea, Minnesota, United States, 56007
Contact: Mina Hanna, MD    612-624-2620    ccinfo@umn.edu   
Essentia Health St. Joseph's Medical Center Recruiting
Brainerd, Minnesota, United States, 56401
Essentia Health Deer River Clinic Recruiting
Deer River, Minnesota, United States, 56636
Contact: Tammie Mlodozyniec         
Essentia Health St Mary's Detroit Lakes Clinic Recruiting
Detroit Lakes, Minnesota, United States, 56501
Contact: Tammie Mlodozyniec         
Essentia Health Duluth Clinic Recruiting
Duluth, Minnesota, United States, 55805
Contact: Tammie Mlodozyniec    218-786-1018    tammie.mlodozyniec@essentiahealth.org   
Principal Investigator: Bret Friday, MD, PhD         
Essentia Health Fosston Recruiting
Fosston, Minnesota, United States, 56542
Contact: Tammie Mlodozyniec         
Essentia Health Hibbing Clinic Recruiting
Hibbing, Minnesota, United States, 55746
Contact: Tammie Mlodozyniec         
Mayo Clinic Health System - Mankato Recruiting
Mankato, Minnesota, United States, 56001
Contact: Stephan Thome    612-624-2620    ccinfo@umn.edu   
Monticello Cancer center Recruiting
Monticello, Minnesota, United States, 55362
Contact: Yan Ji, MD    612-624-2620    ccinfo@umn.edu   
Essentia Health Park Rapids Recruiting
Park Rapids, Minnesota, United States, 56470
Contact: Tammie Mlodozyniec         
Essentia Health Sandstone Recruiting
Sandstone, Minnesota, United States, 55072
Contact: Tammie Mlodozyniec         
Essentia Health Virginia Clinic Recruiting
Virginia, Minnesota, United States, 55792
Contact: Tammie Mlodozyniec         
United States, North Dakota
Essentia Health Fargo Recruiting
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Essentia Health
Minnesota Cancer Clinical Trials Network
Investigators
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Principal Investigator: Bret Friday, MD, PhD Essentia Health
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Responsible Party: Essentia Health
ClinicalTrials.gov Identifier: NCT05454189    
Other Study ID Numbers: MNCCTN024
EH21C1 ( Other Identifier: Essentia Health )
EH22738 ( Other Identifier: Essentia Health )
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months after study completion and for 36 months
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Flushing
Skin Manifestations